Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 48
- Latest Decision
- 2025-12-22
Clearances · page 3 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | FGE | Class II | 2025-12-22 |
| K253664 | SKOUT system | Iterative Health | QNP | Class II | 2025-12-22 |
| K251469 | Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | FAD | Class II | 2025-12-19 |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | NEZ | Class II | 2025-12-19 |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | FDX | Class II | 2025-12-18 |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2025-12-18 |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | PKL | Class II | 2025-12-18 |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | Class II | 2025-12-16 |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. | FGB | Class II | 2025-12-16 |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | Pentax of America, Inc. | FDS | Class II | 2025-12-16 |
| K252675 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2025-12-15 |
| K252391 | Revi System | Bluewind Medical , Ltd. | QXM | Class II | 2025-12-12 |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | KNW | Class II | 2025-12-12 |
| K252504 | Gastric Alimetry | Alimetry , Ltd. | MYE | Class II | 2025-12-05 |
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) | FAS | Class II | 2025-12-05 |
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | FFX | Class II | 2025-12-05 |
| K252069 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2025-12-02 |
| K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | FBK | Class II | 2025-12-02 |
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | KNS | Class II | 2025-11-26 |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | KNS | Class II | 2025-11-25 |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | GCJ | Class II | 2025-11-22 |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | GCJ | Class II | 2025-11-20 |
| K251910 | Focal One® | Edap Technomed, Inc. | PLP | Class II | 2025-11-19 |
| K253411 | Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG | FGB | Class II | 2025-11-18 |
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | 2025-11-14 |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | 2025-11-12 |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Olympus Medical Systems Corp. | OWN | Class II | 2025-11-12 |
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | FDS | Class II | 2025-10-31 |
| K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. | FGB | Class II | 2025-10-31 |
| K252442 | Kii Structural Balloon Access System | Applied Medical Resources Corp. | GCJ | Class II | 2025-10-31 |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | 2025-10-29 |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | FCG | Class II | 2025-10-24 |
| K253226 | UV5000W Handle | Uroviu Corporation | FAJ | Class II | 2025-10-23 |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | FGE | Class II | 2025-10-21 |
| K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | GCJ | Class II | 2025-10-20 |
| K250145 | Biopsy Port Adapter | Endosound, Inc. | ODC | Class II | 2025-10-17 |
| DEN240076 | Modius Lean | Neurovalens Limited | SFW | Class I | 2025-10-17 |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | KNS | Class II | 2025-10-17 |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | Olympus Medical Systems Corporation | FBK | Class II | 2025-10-16 |
| K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis | QHH | Class II | 2025-10-16 |
| K251994 | Arthrex Synergy Vision Imaging System | Arthrex, Inc. | GCJ | Class II | 2025-10-16 |
| K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | FDS | Class II | 2025-10-10 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | KNS | Class II | 2025-10-10 |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | 2025-10-09 |
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical, Ltd. | FER | Class II | 2025-10-09 |
| K252910 | Orca Air/Water and Suction Valves | Boston Scientific | ODC | Class II | 2025-10-09 |
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | FED | Class II | 2025-10-07 |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | KGE | Class II | 2025-10-07 |
| K252140 | Heylo System | Coloplast Corp. | EXB | Class I | 2025-10-06 |
| K243968 | Revolve Surgical System | Revolve Surgical, Inc. | GCJ | Class II | 2025-10-03 |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) | Hollister Incorporated | EZD | Class II | 2025-10-03 |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | Shanghai AnQing Medical Instrument Co., Ltd. | FGB | Class II | 2025-10-03 |
| K251426 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2025-10-03 |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | ODG | Class II | 2025-10-03 |
| K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | QNP | Class II | 2025-10-03 |
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | Simergent, LLC | FKX | Class II | 2025-10-02 |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | FJK | Class II | 2025-10-02 |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. | GCJ | Class II | 2025-10-02 |
| K251767 | Vena MicroAngioscope System | Vena Medical Holdings Corp | LYK | Class II | 2025-10-01 |
| K251104 | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | KNS | Class II | 2025-09-29 |
| K250659 | LoFric Origo | Wellspect AB | EZD | Class II | 2025-09-26 |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | OCX | Class II | 2025-09-26 |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | FDA | Class II | 2025-09-26 |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | OCX | Class II | 2025-09-25 |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | FDF | Class II | 2025-09-24 |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Boston Scientific Corporation | FGB | Class II | 2025-09-24 |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | KNW | Class II | 2025-09-24 |
| K251734 | ProVee Video Processing Unit (PV-003) | Proverum Limited | FET | Class II | 2025-09-24 |
| K251140 | Zenflow Spring Scope | Zenflow, Inc. | FAJ | Class II | 2025-09-23 |
| K251743 | SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | GCJ | Class II | 2025-09-22 |
| K250128 | Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | FED | Class II | 2025-09-19 |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | FDT | Class II | 2025-09-19 |
| K243920 | Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. | KDI | Class II | 2025-09-19 |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | FAJ | Class II | 2025-09-15 |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC | FBN | Class II | 2025-09-12 |
| K252586 | CADDIE | Odin Medical Limited | QNP | Class II | 2025-09-12 |
| K250797 | UV5000 Handle | Uroviu Corporation | FAJ | Class II | 2025-09-11 |
| K251817 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2025-09-10 |
| K252181 | AquaA | Fresenius Medical Care North America | FIP | Class II | 2025-09-09 |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2025-09-09 |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2025-09-08 |
| K251227 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | 2025-09-08 |
| K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | FED | Class II | 2025-09-05 |
| K251026 | Regenesis EMS Chair | Trinity Medical Solutions | KPI | Class II | 2025-08-29 |
| K251324 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2025-08-29 |
| K252350 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | 2025-08-28 |
| K251068 | KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. | OCT | Class II | 2025-08-27 |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | Seplou (Zhuhai) Co., Ltd. | FGB | Class II | 2025-08-26 |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | FCG | Class II | 2025-08-21 |
| K251229 | EndoFixTissue Fixation System | Softac Medical Technologies | FGE | Class II | 2025-08-20 |
| K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix | QSM | Class II | 2025-08-20 |
| K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | Rebotix | QSM | Class II | 2025-08-19 |
| K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | Rebotix | QSM | Class II | 2025-08-19 |
| K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) | Rebotix | QSM | Class II | 2025-08-19 |
| K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation | FIE | Class II | 2025-08-15 |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & CO. KG | FAJ | Class II | 2025-08-13 |
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | NQJ | Class II | 2025-08-13 |
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. | MPB | Class II | 2025-08-12 |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | FET | Class II | 2025-08-11 |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FAJ | Class II | 2025-08-08 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.