Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 48
- Latest Decision
- 2023-01-13
Clearances · page 10 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F | Potrero Medical, Inc. | EZL | Class II | 2023-01-13 |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Health Line International Corporation | NIE | Class II | 2023-01-13 |
| K223031 | Vibrant System | Vibrant, Ltd. | QTN | Class II | 2023-01-13 |
| K221252 | Scivita 4KINSIGHT ICG Imaging System | Scivita Medical Technology Co., Ltd. | GCJ | Class II | 2023-01-13 |
| K222011 | HandX Instrument - Monopolar Spatula | Human Xtensions , Ltd. | GCJ | Class II | 2023-01-12 |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | Fujifilm Corporaton | FDA | Class II | 2023-01-11 |
| K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | ODG | Class II | 2022-12-30 |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode | Well-Life Healthcare Limited | KPI | Class II | 2022-12-29 |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App | Iren-Medical, Ltd. | FKX | Class II | 2022-12-29 |
| K223592 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific Corporation | FGE | Class II | 2022-12-29 |
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) | Olympus Medical Systems Corp. | FAJ | Class II | 2022-12-29 |
| K221054 | CORE-INJECTOR | Incore Co., Ltd. | FBK | Class II | 2022-12-21 |
| K221004 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | GCJ | Class II | 2022-12-20 |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | KOD | Class II | 2022-12-16 |
| K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2022-12-16 |
| K220667 | Sleeved IC | Hollister Incorporated | EZD | Class II | 2022-12-08 |
| K212567 | PVC Hydrophilic Urethral Catheter | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | EZD | Class II | 2022-12-07 |
| K222575 | HurriChem Device Kit | Thermasolutions, LLC | GCJ | Class II | 2022-12-06 |
| K220611 | SUREcore Plus Biopsy Instrument | Uro-1, Inc. | KNW | Class II | 2022-12-02 |
| K221590 | NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | NEZ | Class II | 2022-12-02 |
| K221401 | Self-Cath and Self-Cath Plus | Coloplast | EZD | Class II | 2022-12-02 |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | EZL | Class II | 2022-12-01 |
| K213943 | SmartSurgN Visualization System | Smartsurgn Incorporated | OWN | Class II | 2022-11-29 |
| K212736 | Canady Flex RoboWrist | Us Medical Innovations, LLC | GCJ | Class II | 2022-11-22 |
| K221608 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether | Anx Robotica Corp | QKZ | Class II | 2022-11-22 |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | NAY | Class II | 2022-11-22 |
| K220846 | CORE-SNARE | Incore Co., Ltd. | FDI | Class II | 2022-11-21 |
| K222980 | Pentax Medical Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | ODC | Class II | 2022-11-21 |
| K222535 | OCS Lung Donor Flush Set | TransMedics, Inc. | MSB | Class II | 2022-11-18 |
| K221580 | Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | FAJ | Class II | 2022-11-18 |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | Convatec, Inc. | EZD | Class II | 2022-11-17 |
| K213217 | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | PKL | Class II | 2022-11-14 |
| K223171 | AquaPulse® Irrigation Tubing | Ga Health Company Limited | OCX | Class II | 2022-11-10 |
| K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies, Ltd. | KDI | Class II | 2022-11-10 |
| K222504 | H1 | Karl Storz Endoscopy America, Inc. | GCJ | Class II | 2022-11-10 |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg | Boston Scientific Corporation | FAD | Class II | 2022-11-10 |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | FAJ | Class II | 2022-11-09 |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | Diversatek Healthcare | OCX | Class II | 2022-11-08 |
| K222085 | Standard Tapered Bougie, 38 Fr. | Standard Bariatrics, Inc. | KNT | Class II | 2022-10-31 |
| K222318 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | 2022-10-31 |
| K223020 | VS3-Iridium System (VS3-IR) | Visionsense, Ltd. | OWN | Class II | 2022-10-28 |
| K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | PIF | Class II | 2022-10-27 |
| K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2022-10-27 |
| K220165 | Enteral Transition Adaptor | GBUK Group, Ltd. | PIO | Class II | 2022-10-21 |
| K221740 | SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) | Smith and Nephew, Inc. | GCJ | Class II | 2022-10-20 |
| K222827 | da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | 2022-10-20 |
| K222890 | RADIANCE ULTRA 32 4K ZEROWIRE DUO | Nds Surgical Imaging, LLC | GCJ | Class II | 2022-10-19 |
| K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | Reprocessing Products Corporation (Rpc) | MSY | Class II | 2022-10-18 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | KOD | Class II | 2022-10-13 |
| K222079 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | GCJ | Class II | 2022-10-11 |
| K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | Changzhou Endoclean Medical Device Co., Ltd. | OCX | Class II | 2022-10-07 |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | FGB | Class II | 2022-10-05 |
| K222354 | Elastic Traction System | Micro-Tech (Nanjing) Co., Ltd. | QSW | Class II | 2022-10-03 |
| K210478 | 8mm Monopolar Curved Scissors | Iconocare Health | QSM | Class II | 2022-09-30 |
| K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | Steris | NVE | Class II | 2022-09-30 |
| K212316 | DoubleChek DC-1001 | Nasogastric Feeding Solutions, Ltd. | KNT | Class II | 2022-09-30 |
| K222627 | EndoGI S-Path Biliary Stent System | Endo GI Medical | FGE | Class II | 2022-09-28 |
| K220081 | CORE-SPORT | Incore Co., Ltd. | OTJ | Class II | 2022-09-28 |
| K220785 | Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | OCX | Class II | 2022-09-27 |
| K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) | Zhuhai Pusen Medical Technology Co., Ltd. | FAJ | Class II | 2022-09-26 |
| K220089 | Disposable Polyp Snare | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | FDI | Class II | 2022-09-22 |
| K222059 | SpeediCath Flex Set | Coloplast | EZD | Class II | 2022-09-21 |
| K222542 | MCB UNIT Model: V10GMCBUS | Lamidey Noury Medical | KNS | Class II | 2022-09-21 |
| K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | Boston Scientific Corporation | PKL | Class II | 2022-09-14 |
| K213575 | Female IC (Not Finalized) | Hollister Incorporated | EZD | Class II | 2022-09-13 |
| K221533 | Plasma Shield | Plasmatica, Ltd. | GCJ | Class II | 2022-09-12 |
| K221331 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | ODC | Class II | 2022-09-08 |
| K220595 | NeoNavia Biopsy System | Neodynamics AB | KNW | Class II | 2022-09-08 |
| K222020 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | NWB | Class II | 2022-09-08 |
| K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | 2022-09-07 |
| K211858 | TULSA-PRO System | Profound Medical, Inc. | PLP | Class II | 2022-09-06 |
| K221929 | Smith+Nephew INTELLIO Tablet | Smith+Nephew | ODA | Class II | 2022-09-06 |
| K221085 | LiNA OperaScope Needle | Lina Medical Aps | FBK | Class II | 2022-09-02 |
| K222279 | Rusch Intermittent Urethral Catheters | Teleflex Medical | EZC | Class II | 2022-08-29 |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | FGB | Class II | 2022-08-26 |
| DEN210052 | Vibrant System | Vibrant, Ltd. | QTN | Class II | 2022-08-26 |
| K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | Steris | NVE | Class II | 2022-08-25 |
| K221365 | LapBox Tissue Containment Removal System | Ark Surgical, Ltd. | GCJ | Class II | 2022-08-25 |
| K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | FBK | Class II | 2022-08-19 |
| K222130 | 1688 4K Camera System with Advanced Imaging Modality | Stryker | GCJ | Class II | 2022-08-19 |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | ODG | Class II | 2022-08-19 |
| K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 | Cipher Surgical Limited | OCX | Class II | 2022-08-19 |
| K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | Intuitive Surgical, Inc. | NAY | Class II | 2022-08-15 |
| K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | PLL | Class II | 2022-08-12 |
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | KPO | Class II | 2022-08-12 |
| K213686 | SKOUT Software | Iterative Scopes, Inc. | QNP | Class II | 2022-08-12 |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | Ovesco Endoscopy AG | PLL | Class II | 2022-08-11 |
| K221177 | Erbe's Tubing/Cap Sets | Erbe USA, Inc. | OCX | Class II | 2022-08-11 |
| K221124 | MANTIS Clip | Boston Scientific Corporation | PKL | Class II | 2022-08-04 |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Fujifilm Corporation | ODG | Class II | 2022-08-04 |
| K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | KDI | Class II | 2022-07-29 |
| K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | FBK | Class II | 2022-07-29 |
| K220063 | Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FDX | Class II | 2022-07-28 |
| K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | KNT | Class II | 2022-07-28 |
| K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | FIP | Class II | 2022-07-27 |
| DEN210032 | AccuMeasure System | RQMIS, Inc. | QTH | Class II | 2022-07-26 |
| K212407 | Gastric Lightguide (GLG) | Naser Dib Gabinet Lekarksi Nasmed | KNT | Class II | 2022-07-26 |
| K213773 | Insufflation Retention Device | Bpendo, LLC | FDF | Class II | 2022-07-21 |
| K220161 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | KPI | Class II | 2022-07-20 |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | Apollo Endosurgery, Inc. | QTD | Class II | 2022-07-12 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.