Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 49
- Latest Decision
- 2024-06-03
Clearances · page 7 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | PKL | Class II | 2024-06-03 |
| K233591 | Stylus | Degania Silicone , Ltd. | KNT | Class II | 2024-05-31 |
| K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2024-05-31 |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical | NAY | Class II | 2024-05-24 |
| K233386 | Monik - Disposable Endoscopic Trocar | M/s. Meril Endo Surgery Private Limited. | GCJ | Class II | 2024-05-24 |
| K233442 | troCarWash System | Biotex, Inc. | OCX | Class II | 2024-05-21 |
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences | KNT | Class II | 2024-05-16 |
| K240374 | Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FGB | Class II | 2024-05-10 |
| K240276 | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | Given Imaging Ltd. (D.B.A. Medtronic) | NEZ | Class II | 2024-05-10 |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2024-05-10 |
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical, Inc. | PLP | Class II | 2024-05-09 |
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG | FJL | Class II | 2024-05-07 |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | KNT | Class II | 2024-05-06 |
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | FFX | Class II | 2024-05-06 |
| K232776 | Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer | Outset Medical, Inc. | KDI | Class II | 2024-05-03 |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | Hollister Incorporated | EZD | Class II | 2024-05-03 |
| K240037 | Revi System | Bluewind Medical , Ltd. | QXM | Class II | 2024-05-02 |
| K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps | CenterPoint Systems, LLC | FBN | Class II | 2024-05-02 |
| K240925 | DuraGraft Vascular Conduit Solution | Marizyme | QEJ | Class II | 2024-05-01 |
| K232370 | Percutaneous Nephroscope System | Karl Storz SE & CO. KG | FGA | Class II | 2024-05-01 |
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | ODE | Class II | 2024-04-26 |
| K232405 | ENDOFIX EXO | Aktormed GmbH | OCV | Class II | 2024-04-25 |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Laborie Medical Technologies, Corp. | KLA | Class II | 2024-04-23 |
| K240781 | SKOUT® system | Iterative Scopes, Inc. | QNP | Class II | 2024-04-19 |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | EZL | Class II | 2024-04-17 |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | KNT | Class II | 2024-04-17 |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2 | Ambu A/S | FDT | Class II | 2024-04-16 |
| K240205 | Ez Catch Auto; Ez Catch YR; Ez Catch TR | Veol Medical Technologies Pvt , Ltd. | GCJ | Class II | 2024-04-15 |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | EZL | Class II | 2024-04-15 |
| K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | FBK | Class II | 2024-04-12 |
| K233034 | Mobility+ Enteral Feeding System OTC | Rockfield Medical | PIF | Class II | 2024-04-12 |
| K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | GCJ | Class II | 2024-04-09 |
| K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2 | Ambu A/S | FDS | Class II | 2024-04-05 |
| K240635 | ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm | Ximedica | GCJ | Class II | 2024-04-01 |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | KNS | Class II | 2024-03-29 |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | Gyrus Acmi, Inc. | FGB | Class II | 2024-03-25 |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | ODC | Class II | 2024-03-22 |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | FAD | Class II | 2024-03-22 |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2024-03-19 |
| K232327 | Endorail | Endostart S.R.L. | ODC | Class II | 2024-03-15 |
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Nxstage Medical, Inc. | KDI | Class II | 2024-03-14 |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | Intuitive Surgical, Inc. | NAY | Class II | 2024-03-14 |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | Baxter Healthcare | KDJ | Class II | 2024-03-12 |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | Steris | FBK | Class II | 2024-03-08 |
| K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | ODG | Class II | 2024-03-08 |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | ODC | Class II | 2024-03-06 |
| K231497 | Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FBN | Class II | 2024-03-06 |
| K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | ODC | Class II | 2024-03-06 |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | GCA | Class II | 2024-02-26 |
| K231822 | GOLFF Sterile Anti-Fog Solution | Batrik Medical Manufacturing, Inc. | OCT | Class II | 2024-02-26 |
| K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | Shenzhen Konmed Technology Co., Ltd. | KPI | Class II | 2024-02-23 |
| K240174 | 1688 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | GCJ | Class II | 2024-02-22 |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FDF | Class II | 2024-02-16 |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | FGE | Class II | 2024-02-15 |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | ODC | Class II | 2024-02-09 |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik | KNT | Class II | 2024-02-08 |
| K232171 | Purema® H Hemoconcentrator (EtO Sterilized) | Tecnoideal America | KDI | Class II | 2024-02-07 |
| K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | FED | Class II | 2024-02-02 |
| K231534 | 5008X Hemodialysis System | Fresenius Medical Care | KDI | Class II | 2024-02-02 |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | KNT | Class II | 2024-01-26 |
| K232450 | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. | PKL | Class II | 2024-01-26 |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | Convatec | EZD | Class II | 2024-01-25 |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | EZL | Class II | 2024-01-23 |
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector | Cair Lgl | PIO | Class II | 2024-01-22 |
| K230133 | Plenity | Gelesis, Inc. | QFQ | Class II | 2024-01-19 |
| K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | GCJ | Class II | 2024-01-18 |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | Zmi Electronics , Ltd. | KPI | Class II | 2024-01-18 |
| K233190 | ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd | PIO | Class II | 2024-01-18 |
| K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | KPO | Class II | 2024-01-18 |
| K231135 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | 2024-01-17 |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical, Inc. | KNW | Class II | 2024-01-17 |
| K232062 | Uni-port | Dalim Medical Corp. | OTJ | Class II | 2024-01-16 |
| K222783 | MD Mattress Suture Placement Device | Lsi Solutions, Inc. | GCJ | Class II | 2024-01-12 |
| K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | 2024-01-12 |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) | MacroLux Medical Technology Co., Ltd. | FGB | Class II | 2024-01-11 |
| K231633 | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | PKL | Class II | 2024-01-11 |
| K233327 | 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | GCJ | Class II | 2024-01-09 |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | Anx Robotica Corporation | NEZ | Class II | 2024-01-05 |
| K232519 | ENDOCOLLECT Specimen Retrieval Bag | Ximedica | GCJ | Class II | 2024-01-05 |
| K232518 | EndoSound Vision System; EVS | Endosound, Inc. | ODG | Class II | 2023-12-27 |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | NQJ | Class II | 2023-12-26 |
| K230439 | WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. | FER | Class II | 2023-12-22 |
| K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | PLQ | Class II | 2023-12-21 |
| K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | Medivators (A Subsidiary of Steris Corporation) | ODC | Class II | 2023-12-21 |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | KNT | Class II | 2023-12-18 |
| K231066 | CuratOR EX3242-FD | Eizo Corporation | GCJ | Class II | 2023-12-18 |
| K230751 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | QNP | Class II | 2023-12-15 |
| K231721 | Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. | KGE | Class II | 2023-12-14 |
| K232283 | PhySoftAMS® | Physician Software Systems, LLC | MQS | Class II | 2023-12-14 |
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection | Boston Scientific Corporation - | FGB | Class II | 2023-12-12 |
| DEN230027 | NaviCam ProScan | Ankon Technologies Co., Ltd. | QZF | Class II | 2023-12-12 |
| K232830 | Vibrant System | Vibrant, Ltd. | QTN | Class II | 2023-12-08 |
| K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2023-12-06 |
| K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | KDI | Class II | 2023-12-05 |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | Pentax of America, Inc. | ODC | Class II | 2023-12-01 |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2023-12-01 |
| K232262 | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | Surgease Innovations Limited | FAN | Class II | 2023-11-30 |
| K230646 | SUREcore Prime Biopsy Instrument | Uro-1 Medical, Inc. | KNW | Class II | 2023-11-29 |
| K232244 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | ODC | Class II | 2023-11-29 |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific | KNS | Class II | 2023-11-28 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.