Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 51
- Latest Decision
- 2025-04-10
Clearances · page 5 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | KNT | Class II | 2025-04-10 |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2025-04-04 |
| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | 2025-04-03 |
| K242067 | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Olympus Corporations of the Americas | FET | Class II | 2025-04-02 |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | 2025-04-01 |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | KDN | Class II | 2025-03-31 |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | KNT | Class II | 2025-03-28 |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | Scivita Medical Technology Co., Ltd. | FGB | Class II | 2025-03-27 |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. | KPI | Class II | 2025-03-27 |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | KDN | Class II | 2025-03-26 |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | KNS | Class II | 2025-03-26 |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) | Bright Uro, Inc. | EXQ | Class II | 2025-03-24 |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | Class II | 2025-03-21 |
| K250517 | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 | Boston Scientific Corporation | FED | Class II | 2025-03-21 |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | Class II | 2025-03-21 |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2025-03-21 |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | OCX | Class II | 2025-03-20 |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | ODC | Class II | 2025-03-19 |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. | LQR | Class II | 2025-03-18 |
| K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | FIP | Class II | 2025-03-17 |
| K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | GCJ | Class II | 2025-03-17 |
| K242323 | Maestro System (REF100) | Moon Surgical | QZB | Class II | 2025-03-14 |
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | Dannik, LLC | GCJ | Class II | 2025-03-12 |
| K242610 | 8mm Monopolar Curved Scissors (470179) | Iconocare Health | QSM | Class II | 2025-03-11 |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | FBN | Class II | 2025-03-07 |
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co., Ltd. | GBM | Class II | 2025-03-05 |
| K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2025-02-28 |
| K243582 | da Vinci SP Advanced Access Port Kit (432701) | Intuitive Surgical, Inc. | NAY | Class II | 2025-02-28 |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | KNW | Class II | 2025-02-27 |
| K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. | FBK | Class II | 2025-02-27 |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | ODC | Class II | 2025-02-20 |
| K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | OWN | Class II | 2025-02-19 |
| K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | KLA | Class II | 2025-02-12 |
| K243155 | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) | Dongguan Zsr Biomedical Technology Company Limited | FGB | Class II | 2025-02-11 |
| K241897 | MOR | Morari, Inc. | QRC | Class II | 2025-02-11 |
| K241516 | BTL-398 | BTL Industries, Inc. | KPI | Class II | 2025-02-10 |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FET | Class II | 2025-02-07 |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation | PKL | Class II | 2025-02-06 |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | KNS | Class II | 2025-02-06 |
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | Dornier Medtech America | FED | Class II | 2025-01-31 |
| K243025 | Ureteral Access Sheath | Seplou (Zhuhai) Co., Ltd. | FED | Class II | 2025-01-30 |
| K243117 | Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | 2025-01-29 |
| K243439 | Medical Monitor (27HS714S) | Lg Electronics.Inc | GCJ | Class II | 2025-01-28 |
| K244023 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | QNP | Class II | 2025-01-24 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | KNW | Class II | 2025-01-24 |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | KNW | Class II | 2025-01-24 |
| K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | KDL | Class II | 2025-01-24 |
| K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | Hunan Endoso Life Technology Co., Ltd. | FGB | Class II | 2025-01-22 |
| K243008 | Arthrex NanoScope System | Arthrex, Inc. | GCJ | Class II | 2025-01-22 |
| K241444 | Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FBN | Class II | 2025-01-21 |
| K242336 | hygh-tec Drainage II | Amb Medtec | KNT | Class II | 2025-01-17 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | KNS | Class II | 2025-01-17 |
| K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | PLQ | Class II | 2025-01-15 |
| K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | PNG | Class II | 2025-01-14 |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | Tools For Surgery, LLC | KNT | Class II | 2025-01-10 |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. | KNW | Class II | 2025-01-10 |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | FDF | Class II | 2025-01-03 |
| K241005 | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | PKL | Class II | 2025-01-02 |
| K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | FGE | Class II | 2024-12-20 |
| K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | Envision Endoscopy | OCZ | Class II | 2024-12-20 |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 ) | Diality, Inc. | FJK | Class II | 2024-12-20 |
| K243361 | Nutrifit | Vygon USA | FPD | Class II | 2024-12-19 |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | Cardinalhealth | PNR | Class II | 2024-12-19 |
| K241168 | System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. | FEB | Class II | 2024-12-19 |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | FAJ | Class II | 2024-12-18 |
| K241801 | Tornus ES | Asahi Intecc Co., Ltd. | FGE | Class II | 2024-12-17 |
| K243471 | Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | LQR | Class II | 2024-12-16 |
| K243641 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | 2024-12-16 |
| K243196 | Uro-G HD Cystoscope (1520) | Uroviu Corporation | FAJ | Class II | 2024-12-13 |
| K243307 | LCD Monitor (MDEC-2523) | Barco N.V. | GCJ | Class II | 2024-12-13 |
| K242668 | Gastro Concepts Air Assist | Gastro Concepts, LLC | FER | Class II | 2024-12-13 |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | KNS | Class II | 2024-12-12 |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | Bard Peripheral Vascular, Inc. | PNG | Class II | 2024-12-06 |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | Pentax of America, Inc. | FDS | Class II | 2024-12-06 |
| K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | FGE | Class II | 2024-12-06 |
| K242304 | RED | Neuraxis, Inc. | KLA | Class II | 2024-12-06 |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Alcon Laboratories, Inc. | MPA | Class II | 2024-12-04 |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | NEZ | Class II | 2024-12-04 |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | FEB | Class II | 2024-12-02 |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) | Easymed Instruments Co., Ltd. | KPI | Class II | 2024-11-27 |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG | FBO | Class II | 2024-11-27 |
| K242318 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2024-11-26 |
| K240650 | LungProtect | Traferox Technologies, Inc. | KDN | Class II | 2024-11-26 |
| K242049 | SureCath Set | Coloplast Corp. | EZD | Class II | 2024-11-26 |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | KNT | Class II | 2024-11-22 |
| K242927 | Suction Irrigation Tubing Set | Advamedix, GmbH | GCJ | Class II | 2024-11-22 |
| K241210 | Luja Coude | Coloplast Corp. | EZD | Class II | 2024-11-21 |
| K241814 | da Vinci SP Instruments (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2024-11-18 |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | Coloplast Corp. | FED | Class II | 2024-11-12 |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | STERIS Corporation | ODC | Class II | 2024-11-08 |
| K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) | Rebotix | QSM | Class II | 2024-11-07 |
| K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | GCJ | Class II | 2024-11-06 |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | KOB | Class II | 2024-11-01 |
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) | Quanta Dialysis Technologies, Ltd. | ONW | Class II | 2024-11-01 |
| K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | FED | Class II | 2024-11-01 |
| DEN230082 | Stone Clear (SC-LP9-01) | Sonomotion, Inc. | QNA | Class II | 2024-10-30 |
| K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | FCX | Class II | 2024-10-30 |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) | Lagis Enterprise Co., Ltd. | GCJ | Class II | 2024-10-30 |
| K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis | QHH | Class II | 2024-10-30 |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | Devicor Medical Products, Inc. | KNW | Class II | 2024-10-29 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.