Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 43
- Latest Decision
- 2024-10-25
Clearances · page 6 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | KNT | Class II | 2024-10-25 |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | 2024-10-23 |
| K234060 | KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies | KDN | Class II | 2024-10-23 |
| K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | OCV | Class II | 2024-10-22 |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | FET | Class II | 2024-10-22 |
| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 | Ambu A/S | FAJ | Class II | 2024-10-16 |
| K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | LQR | Class II | 2024-10-15 |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | ODC | Class II | 2024-10-11 |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | FDS | Class II | 2024-10-11 |
| K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance | Ambu A/S | FAJ | Class II | 2024-10-10 |
| K242029 | TRAP EASY | H.S Hospital Service S.P.A | KNW | Class II | 2024-10-09 |
| K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | FED | Class II | 2024-10-08 |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corporation | OCX | Class II | 2024-10-07 |
| K240074 | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) | Shenzhen Besdata Technology Co., Ltd. | FGB | Class II | 2024-10-04 |
| K241052 | Bladeless Trocar; Bladed Trocar; Hasson Trocar | Advamedix, GmbH | GCJ | Class II | 2024-10-04 |
| K241434 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | 2024-10-04 |
| K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC | GCJ | Class II | 2024-10-04 |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | FDF | Class II | 2024-10-04 |
| K240675 | Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co., Ltd. | FBK | Class II | 2024-10-04 |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | ODC | Class II | 2024-10-01 |
| K241874 | Aspiration Catheter (2189) | Hobbs Medical, Inc. | OCX | Class II | 2024-09-24 |
| K241424 | InnoCare Specialty Foley Catheter | Innocare Urologics, LLC | EZL | Class II | 2024-09-18 |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | PKL | Class II | 2024-09-17 |
| K240544 | Epitomee | Epitomee Medical , Ltd. | QFQ | Class II | 2024-09-13 |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | Intuitive Surgical, Inc. | NAY | Class II | 2024-09-10 |
| K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV | QIS | Class II | 2024-09-06 |
| K232543 | MSC SFM | Yocon Biology Technology Company | NDS | Class II | 2024-09-06 |
| K240203 | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) | Dyne Medical Group, Inc. | FGB | Class II | 2024-09-05 |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | FDS | Class II | 2024-09-04 |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific | FGE | Class II | 2024-08-30 |
| K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | GCJ | Class II | 2024-08-28 |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | FBK | Class II | 2024-08-27 |
| K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | PKL | Class II | 2024-08-26 |
| K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | Lina Medical Aps | FAJ | Class II | 2024-08-22 |
| K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | OCX | Class II | 2024-08-20 |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA | OWN | Class II | 2024-08-19 |
| K233700 | Avicenna Roboflex | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi | FGB | Class II | 2024-08-16 |
| K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance | Ambu A/S | FGB | Class II | 2024-08-16 |
| K241401 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | GCJ | Class II | 2024-08-15 |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | KNS | Class II | 2024-08-15 |
| K241402 | Medical Monitor (32HR734S) | Lg Electronics.Inc | GCJ | Class II | 2024-08-12 |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | KNW | Class II | 2024-08-09 |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | Aktormed GmbH | QZB | Class II | 2024-08-08 |
| K241530 | Stellar Imaging System | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | 2024-08-07 |
| K241360 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | 2024-08-05 |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | Peregrine Surgical, LLC | MPA | Class II | 2024-08-05 |
| K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | FED | Class II | 2024-08-02 |
| K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | KDI | Class II | 2024-08-02 |
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) | Karl Storz SE & CO. KG | FGB | Class II | 2024-08-01 |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) | Pentax of America, Inc. | FDT | Class II | 2024-08-01 |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | EZL | Class II | 2024-08-01 |
| K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | Anx Robotica Corp | QKZ | Class II | 2024-07-31 |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | FCG | Class II | 2024-07-29 |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | Coloplast | EZD | Class II | 2024-07-26 |
| K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | 2024-07-25 |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | GCJ | Class II | 2024-07-25 |
| K233372 | KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG | FGB | Class II | 2024-07-25 |
| K241502 | P-SCOPE | Oui Medical, Inc. | GCJ | Class II | 2024-07-24 |
| K240044 | CADDIE | Odin Medical Limited | QNP | Class II | 2024-07-24 |
| K233866 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | 2024-07-19 |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | Zhuhai Pusen Medical Technology Co., Ltd. | FGB | Class II | 2024-07-16 |
| K241739 | Endoscopic Applicator, 41 cm | Micromedics, Inc. | GCJ | Class II | 2024-07-15 |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FAJ | Class II | 2024-07-12 |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research and Development | KPO | Class II | 2024-07-12 |
| K233557 | HemoCare Hemodialysis System | Deka Research and Development | KDI | Class II | 2024-07-12 |
| K240247 | MoFi Cell Culture Basal Medium | Duogenic Stemcells Corporation | NDS | Class II | 2024-07-12 |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | PKL | Class II | 2024-07-12 |
| K240502 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2024-07-08 |
| K241111 | AMT Suture Passer | Applied Medical Technology, Inc. | GCJ | Class II | 2024-07-05 |
| K240946 | Gastric Alimetry | Alimetry , Ltd. | MYE | Class II | 2024-07-03 |
| K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | 2024-07-03 |
| K241508 | SKOUT® system | Iterative Scopes, Inc. | QNP | Class II | 2024-07-03 |
| K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | PIF | Class II | 2024-07-03 |
| K241591 | Blue Eye | The Standard Co., Ltd. | PLL | Class II | 2024-07-03 |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | FET | Class II | 2024-07-03 |
| K234061 | StarFormer | Fotona D.O.O. | KPI | Class II | 2024-07-01 |
| K241639 | Single-use Video Ureterorenoscope (SVU-220US) | Huger Medical Instrument Co., Ltd. | FGB | Class II | 2024-07-01 |
| K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500) | Boston Scientific Corporation | FGB | Class II | 2024-07-01 |
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | FIB | Class II | 2024-06-28 |
| K240853 | Pathfinder® CR System | Neptune Medical, Inc. | FED | Class II | 2024-06-27 |
| K233840 | Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) | Zhuhai Dipu Medical Technology Co., Ltd. | GCJ | Class II | 2024-06-26 |
| K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2 | Ambu A/S | FGB | Class II | 2024-06-24 |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FAJ | Class II | 2024-06-21 |
| K233240 | GERDX-System | G-Surg GmbH | ODE | Class II | 2024-06-21 |
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | Schoelly Fiberoptic GmbH | GCJ | Class II | 2024-06-20 |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | FDS | Class II | 2024-06-19 |
| K240196 | Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) | Yuwonmeditech Co., Ltd. | GCJ | Class II | 2024-06-18 |
| K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | Itp Innovative Tomography Products GmbH | KNW | Class II | 2024-06-18 |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | Cook Ireland, Ltd. | FGE | Class II | 2024-06-14 |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation | FDA | Class II | 2024-06-13 |
| K233892 | 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) | Zhuhai Dipu Medical Technology Co., Ltd. | GCJ | Class II | 2024-06-13 |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | 2024-06-13 |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | FAS | Class II | 2024-06-12 |
| K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) | Karl Storz Endovision, Inc. | FGB | Class II | 2024-06-10 |
| K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | MacroLux Medical Technology Co., Ltd. | FAJ | Class II | 2024-06-10 |
| K232837 | Uro-G HD Flexible Cystoscope | Uroviu Corporation | FAJ | Class II | 2024-06-07 |
| K232969 | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | PKL | Class II | 2024-06-07 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | KNT | Class II | 2024-06-06 |
| K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | MJC | Class II | 2024-06-06 |
| K232773 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2024-06-04 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.