Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 47
- Latest Decision
- 2025-08-08
Clearances · page 4 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | KNS | Class II | 2025-08-08 |
| K250130 | Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) | Hangzhou Viction Medical Technology Co.,Ltd | GCJ | Class II | 2025-08-06 |
| K250124 | Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) | Hangzhou Viction Medical Technology Co.,Ltd | GCJ | Class II | 2025-08-06 |
| K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | KDI | Class II | 2025-08-01 |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo | American Medical Endoscopy, Inc. | FAJ | Class II | 2025-08-01 |
| K250442 | da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. | NAY | Class II | 2025-07-29 |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | KNW | Class II | 2025-07-29 |
| K252010 | SPY Laparoscope | Stryker Endoscopy | GCJ | Class II | 2025-07-24 |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | Wuxi Hisky Medical Technologies Co., Ltd. | OWN | Class II | 2025-07-24 |
| K251213 | Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | 2025-07-23 |
| K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies | PBP | Class II | 2025-07-22 |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | KNW | Class II | 2025-07-22 |
| K251542 | InstaFAN | Onepass Medical , Ltd. | ODG | Class II | 2025-07-18 |
| K251585 | Profoject Enteral Feeding Syringe | CMT Health PTE., Ltd. | PNR | Class II | 2025-07-18 |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | FGE | Class II | 2025-07-16 |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation | ODC | Class II | 2025-07-16 |
| K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | 2025-07-16 |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | KNW | Class II | 2025-07-11 |
| K250820 | Disposable Trocars | Sinolinks Medical Innovation, Inc. | GCJ | Class II | 2025-07-11 |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | KNW | Class II | 2025-07-10 |
| K250695 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FED | Class II | 2025-07-08 |
| K251599 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | FED | Class II | 2025-07-03 |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific | FGE | Class II | 2025-07-03 |
| K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | Intuitive Surgical, Inc. | GCJ | Class II | 2025-07-02 |
| K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | GCJ | Class II | 2025-07-02 |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | Convatec | EZD | Class II | 2025-07-01 |
| K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. | FET | Class II | 2025-07-01 |
| K251116 | Luja Coudé | Coloplast Corp. | EZD | Class II | 2025-06-27 |
| K250984 | Maestro System (REF100) | Moon Surgical | QZB | Class II | 2025-06-27 |
| K250522 | Multi4 System | Multi4 Medical AB | FAS | Class II | 2025-06-27 |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | FDS | Class II | 2025-06-27 |
| K250585 | LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. | FED | Class II | 2025-06-27 |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical , Ltd. | KPI | Class II | 2025-06-26 |
| K250940 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | NYV | Class II | 2025-06-26 |
| K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | EZD | Class II | 2025-06-26 |
| K242845 | EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. | FGE | Class II | 2025-06-25 |
| K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | SFE | Class II | 2025-06-24 |
| K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | ODC | Class II | 2025-06-20 |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | LNS | Class II | 2025-06-18 |
| K243039 | Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | FAD | Class II | 2025-06-18 |
| K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | PIF | Class II | 2025-06-18 |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life | KDN | Class II | 2025-06-17 |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | EZL | Class II | 2025-06-16 |
| K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | FDS | Class II | 2025-06-16 |
| K250674 | Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. | NAY | Class II | 2025-06-13 |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2025-06-13 |
| K251209 | Medical Monitor (32HS710S) | Lg Electronics.Inc | GCJ | Class II | 2025-06-12 |
| K250584 | Rezum System | Boston Scientific Corporation | KNS | Class II | 2025-06-11 |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | NAY | Class II | 2025-06-11 |
| K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) | Ambu A/S | FAJ | Class II | 2025-06-11 |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | FDS | Class II | 2025-06-10 |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | Convatec Limited | FCM | Class II | 2025-06-06 |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG | FGB | Class II | 2025-06-06 |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | KNS | Class II | 2025-06-06 |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | FDT | Class II | 2025-06-05 |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Pentax of America, Inc. | PEA | Class II | 2025-06-03 |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | MacroLux Medical Technology Co., Ltd. | FED | Class II | 2025-06-02 |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | FDS | Class II | 2025-05-30 |
| K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2025-05-30 |
| K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | Opcom Medical, Inc. | FGB | Class II | 2025-05-28 |
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | Olympus Medical Systems Corp. | ODD | Class II | 2025-05-27 |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation | FDF | Class II | 2025-05-23 |
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | EZN | Class II | 2025-05-22 |
| K242586 | ArgoCap (200.52) | Ovesco Endoscopy AG | OCX | Class II | 2025-05-22 |
| K250493 | MotiliCap GI Monitoring System | Anx Robotica Corporation | NYV | Class II | 2025-05-21 |
| K242857 | ClearHemograsper | Finemedix Co., Ltd. | KGE | Class II | 2025-05-21 |
| K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | MSD | Class II | 2025-05-16 |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. | FKX | Class II | 2025-05-16 |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | NIKKISO CO., LTD. | KDI | Class II | 2025-05-15 |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation | FDF | Class II | 2025-05-15 |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | NIKKISO CO., LTD. | KOC | Class II | 2025-05-15 |
| K250451 | NeurAxis IB-Stim (01-1020) | Neuraxis | QHH | Class II | 2025-05-15 |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | NIKKISO CO., LTD. | KOC | Class II | 2025-05-15 |
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | FAD | Class II | 2025-05-14 |
| K250786 | SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. | NAY | Class II | 2025-05-13 |
| K251126 | SKOUT system | Iterative Health | QNP | Class II | 2025-05-09 |
| K250785 | Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | 2025-05-06 |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | GCJ | Class II | 2025-05-05 |
| K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions, LLC | MLW | Class II | 2025-05-05 |
| K243894 | F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. | FGB | Class II | 2025-05-02 |
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | Karl Storz SE & CO. KG | FBO | Class II | 2025-05-02 |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | KDN | Class II | 2025-05-01 |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | FDS | Class II | 2025-05-01 |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | KNW | Class II | 2025-04-29 |
| K242211 | PUMA-G Pediatric System | Coaptech, Inc. | KGC | Class II | 2025-04-29 |
| K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions, LLC | FGB | Class II | 2025-04-28 |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | KDN | Class II | 2025-04-25 |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | Sorin Group Italia S.R.L. | KDI | Class II | 2025-04-25 |
| K243714 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2025-04-24 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | KNW | Class II | 2025-04-24 |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | PKL | Class II | 2025-04-18 |
| K250481 | Extension Feeding Set with ENFit Connectors | SKY Medical, a.s. | PIF | Class II | 2025-04-18 |
| K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | PLQ | Class II | 2025-04-17 |
| K243750 | SimpleStitch Suturing System | Envision Endoscopy | OCW | Class II | 2025-04-17 |
| K250270 | Luja Set | Coloplast Corp. | EZD | Class II | 2025-04-17 |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | Boston Scientific Corporation | FAD | Class II | 2025-04-15 |
| K243710 | Disposable ureteral access sheath | Shenzhen Trious Medical Technology Co., Ltd. | FED | Class II | 2025-04-11 |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | FGB | Class II | 2025-04-11 |
| K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. | MSY | Class II | 2025-04-11 |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | FET | Class II | 2025-04-11 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.