Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 49
- Latest Decision
- 2023-07-07
Clearances · page 9 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | OCX | Class II | 2023-07-07 |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | 2023-07-06 |
| K231358 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | 2023-07-05 |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | NEZ | Class II | 2023-06-30 |
| K231267 | ClearTip | Finemedix Co., Ltd. | FCG | Class II | 2023-06-30 |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | FEB | Class II | 2023-06-30 |
| K231553 | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | OCW | Class II | 2023-06-29 |
| K231101 | Flume Catheter | Flume Catheter Company, Ltd. | EZL | Class II | 2023-06-29 |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | Karl Storz Endoscopy America, Inc. | GCJ | Class II | 2023-06-23 |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) | Zhuhai Pusen Medical Technology Co., Ltd. | FBN | Class II | 2023-06-22 |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | KNS | Class II | 2023-06-21 |
| K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | KDI | Class II | 2023-06-21 |
| K230886 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | GCJ | Class II | 2023-06-21 |
| K230015 | OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver | Laurane Medical Sas | KNW | Class II | 2023-06-16 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | NIKKISO CO., LTD. | KOC | Class II | 2023-06-16 |
| K223890 | NAJA Gastrointestinal Catheter | Chess Medical, Inc. | FGD | Class II | 2023-06-16 |
| K223469 | WallFlex Biliary RX Stent System | Boston Scientific Corporation | FGE | Class II | 2023-06-15 |
| K231406 | ClearumTM HS | Bellco Srl | KDI | Class II | 2023-06-14 |
| DEN220078 | Eroxon | Futura Medical Developments Limited | QWW | Class II | 2023-06-09 |
| K231042 | Disposable Laparoscopic Trocar | Changzhou Ankang Medical Instruments Co., Ltd. | GCJ | Class II | 2023-06-08 |
| K223718 | HandX Self-Righting Needle Holder | Human Xtensions , Ltd. | GCJ | Class II | 2023-06-05 |
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | I3 Membrane GmbH | NHV | Class II | 2023-06-02 |
| K223562 | Xpan Universal Trocar System | Xpan, Inc. | GCJ | Class II | 2023-06-02 |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | FJK | Class II | 2023-05-31 |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | FCG | Class II | 2023-05-30 |
| K223626 | Niti-S Biliary Speed D Stent | Taewoong Medical Co., Ltd. | FGE | Class II | 2023-05-26 |
| K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | EZD | Class II | 2023-05-22 |
| K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | 2023-05-19 |
| K230200 | Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | 2023-05-18 |
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | 2023-05-12 |
| K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2023-05-11 |
| K230491 | HandX Monopolar Scissors | Human Xtensions , Ltd. | GCJ | Class II | 2023-05-10 |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | Allwin Medical Devices, Inc. | EZN | Class II | 2023-05-05 |
| K223756 | SimPro Now, GentleCath Hydrophilic | Dentsply Sirona | EZD | Class II | 2023-05-04 |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | KNS | Class II | 2023-05-03 |
| K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | PNG | Class II | 2023-05-02 |
| K223595 | vPATCH | Virility Medical , Ltd. | QRC | Class II | 2023-05-01 |
| K230058 | Bladeless Trocar Artemis Lap Cannula | T.A.G. Medical Products Corporation, Ltd. | GCJ | Class II | 2023-04-28 |
| K223398 | Gastric Alimetry System | Alimetry , Ltd. | MYE | Class II | 2023-04-27 |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | Olympus Medical Systems Corporation | FET | Class II | 2023-04-26 |
| K230056 | MiVu Esophageal Endo Cap | Diversatek Healthcare | QIS | Class II | 2023-04-25 |
| K223300 | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument | Geotek Medikal Ltd Sti | KNW | Class II | 2023-04-21 |
| K222261 | Flexible Video-Choledochoscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | FBN | Class II | 2023-04-20 |
| K223705 | EndoflipTM 300 | Covidien, LLC | FFX | Class II | 2023-04-14 |
| K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Anx Robotica Corp | QKZ | Class II | 2023-04-13 |
| K230754 | L12 LED Light Source with AIM | Stryker | OWN | Class II | 2023-04-11 |
| K230658 | SKOUT® system | Iterative Scopes, Inc. | QNP | Class II | 2023-04-07 |
| K222677 | Intermittent nelaton catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | EZD | Class II | 2023-04-05 |
| K223256 | Optimos Cystotome | Taewoong Medical Co., Ltd. | KNS | Class II | 2023-04-05 |
| K230033 | Da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2023-04-05 |
| K222865 | 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 | 2023-04-03 |
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | Avation Medical, Inc. | NAM | Class II | 2023-04-03 |
| K222006 | Sclerotherapy & Endoscopic Needles | G-Flex Europe Sprl | FBK | Class II | 2023-04-03 |
| K230605 | 1788 4K Camera System with Advanced Imaging Modality | Stryker | GCJ | Class II | 2023-03-31 |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | Nova Eye Inc. (Business Name Nova Eye Medical) | MPA | Class II | 2023-03-30 |
| K223923 | HOPKINS Telescopes | KARL STORZ Endoscopy-America, Inc. | GCJ | Class II | 2023-03-30 |
| K223916 | PUMA-G System | Coaptech, Inc. | KGC | Class II | 2023-03-29 |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | FCG | Class II | 2023-03-29 |
| K222146 | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | PKL | Class II | 2023-03-28 |
| K230474 | EVA5 Insufflator | Palliare , Ltd. | FCX | Class II | 2023-03-24 |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | KNT | Class II | 2023-03-24 |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | Taiwan Surgical Corporation | GCJ | Class II | 2023-03-22 |
| K222828 | Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | GCJ | Class II | 2023-03-20 |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | FJL | Class II | 2023-03-17 |
| K223095 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | 2023-03-16 |
| K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | Intuitive Surgical, Inc. | NAY | Class II | 2023-03-16 |
| K222663 | MultiStage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | FGE | Class II | 2023-03-09 |
| K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | Class II | 2023-03-06 |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | KNT | Class II | 2023-03-03 |
| K221652 | NIKKICART | Renal Care Dialysis Solutions, S.A. DE C.V. | KPO | Class II | 2023-03-03 |
| K221713 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | FDI | Class II | 2023-03-03 |
| K223040 | Endo SmartCap | Medivators, Inc. | FAJ | Class II | 2023-03-01 |
| K223116 | 8X-10-6XXX Camera Head | Santa Barbara Imaging Systems | GCJ | Class II | 2023-02-28 |
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | OCX | Class II | 2023-02-27 |
| K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | GCJ | Class II | 2023-02-24 |
| DEN220065 | Pill Sense System | Enterasense , Ltd. | QUD | Class II | 2023-02-24 |
| K223884 | ELITONE Urge Urinary Incontinence Device | Elidah, Inc. | QAJ | Class II | 2023-02-24 |
| K230205 | Veloxion System | Corinth Medtech, Inc. | FJL | Class II | 2023-02-24 |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | Schoelly Fiberoptic GmbH | GCJ | Class II | 2023-02-23 |
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Stryker | GCJ | Class II | 2023-02-23 |
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | LNS | Class II | 2023-02-22 |
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | Ranfac Corporation | KNW | Class II | 2023-02-21 |
| K221861 | FloNavi Endoscopic Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | 2023-02-18 |
| K222695 | troCarWash System | Biotex, Inc. | OCX | Class II | 2023-02-17 |
| K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation | FGB | Class II | 2023-02-17 |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | FBN | Class II | 2023-02-16 |
| K230131 | ReShape Calibration Tubes | Reshape Lifesciences | KNT | Class II | 2023-02-15 |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | FIP | Class II | 2023-02-13 |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | FDF | Class II | 2023-02-10 |
| K221400 | hygh-tec drainage | Creative Balloons GmbH | KNT | Class II | 2023-02-09 |
| K230089 | ETHICON LINX® Esophagus Sizing Tool | Torax Medical, Inc. | QJN | Class II | 2023-02-09 |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | 2023-02-02 |
| K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring | Boston Scientific Corporation | FGB | Class II | 2023-02-02 |
| K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | FDS | Class II | 2023-01-27 |
| K221683 | CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) | Olympus Medical Systems Corporation | FAJ | Class II | 2023-01-20 |
| K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) | Itp Innovative Tomography Products GmbH | KNW | Class II | 2023-01-20 |
| K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | LNS | Class II | 2023-01-19 |
| K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | GCJ | Class II | 2023-01-18 |
| K222000 | Transit-Pellets | Medifactia AB | FFX | Class II | 2023-01-18 |
| K220884 | Disposable Endoscope Valve Sets | Sml Med-Tech Solutions Limited | ODC | Class II | 2023-01-17 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.