Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 52
- Latest Decision
- 2023-11-24
Clearances · page 8 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K230319 | Passio Pump Drainage System | Bearpac Medical | PNG | Class II | 2023-11-24 |
| K222499 | Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. | ODC | Class II | 2023-11-22 |
| K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | OCX | Class II | 2023-11-21 |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | OWN | Class II | 2023-11-21 |
| K232028 | Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) | Iq Endoscopes Limited | FDS | Class II | 2023-11-17 |
| K232925 | Gastric Alimetry System | Alimetry , Ltd. | MYE | Class II | 2023-11-17 |
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | NIE | Class II | 2023-11-16 |
| K231118 | Cystoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FAJ | Class II | 2023-11-13 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | NDS | Class II | 2023-11-09 |
| K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. | FBK | Class II | 2023-11-09 |
| K231798 | da Vinci SP Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2023-11-08 |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. | EZD | Class II | 2023-11-08 |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | KNS | Class II | 2023-11-07 |
| K232866 | Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) | Jiangsu Channel Medical Device Co., Ltd. | GCJ | Class II | 2023-11-07 |
| K232857 | KARL STORZ ICG Imaging System | Karl Storz SE & CO. KG | OWN | Class II | 2023-11-06 |
| K230475 | Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. | FGB | Class II | 2023-11-03 |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | FDF | Class II | 2023-11-03 |
| K230326 | ENFit to ENFit Extension Sets | Vesco Medical | PIF | Class II | 2023-11-02 |
| K232880 | Inzii Ripstop Redeployable Retrieval System | Applied Medical Resources Corporation | GCJ | Class II | 2023-11-01 |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | KNS | Class II | 2023-10-31 |
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Insightec, Ltd. | PLP | Class II | 2023-10-30 |
| K233220 | EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) | Senorx, Inc. | KNW | Class II | 2023-10-27 |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation | KNS | Class II | 2023-10-27 |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. | EZD | Class II | 2023-10-26 |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. | KNS | Class II | 2023-10-25 |
| K230893 | Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A | FEO | Class II | 2023-10-23 |
| K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | Steris | ODC | Class II | 2023-10-20 |
| K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | KPI | Class II | 2023-10-20 |
| K232922 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | FDF | Class II | 2023-10-20 |
| K232042 | NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021); | Mediconcepts Technology (Shenzhen) Company Limited | GCJ | Class II | 2023-10-20 |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | FBN | Class II | 2023-10-17 |
| K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | Hunan Endoso Life Technology Co., Ltd. | GCJ | Class II | 2023-10-16 |
| K232118 | ANDORATE® Valve Kit | Ga Health Company Limited | ODC | Class II | 2023-10-16 |
| K231300 | Nutricair Enteral Syringe with ENFit | Cair Lgl | PNR | Class II | 2023-10-06 |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company | PIF | Class II | 2023-10-06 |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) | FAJ | Class II | 2023-10-06 |
| K230780 | MFG-05 | Zimmer Medizinsysteme GmbH | KPI | Class II | 2023-10-05 |
| DEN230002 | DuraGraft | Marizyme, Inc. | QEJ | Class II | 2023-10-04 |
| K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Anx Robotica Corporation | QKZ | Class II | 2023-10-03 |
| K232918 | enspire 300 Series Automated Endoscope Reprocessor | STERIS Corporation | NZA | Class II | 2023-10-03 |
| K232406 | KARL STORZ OR1 SCB CONTROL (WU300) | Karl Storz SE & CO. KG | ODA | Class II | 2023-10-03 |
| K231622 | REGER Nebulizer Irrigation Cannula | Reger Medizintechnik, GmbH | GCJ | Class II | 2023-09-29 |
| K232701 | Guardenia (GAR-1) | Advanced Surgical Concepts | GCJ | Class II | 2023-09-29 |
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | OTU Medical, Inc. | FAJ | Class II | 2023-09-29 |
| K230925 | Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. | FBK | Class II | 2023-09-27 |
| K232596 | EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. | FGE | Class II | 2023-09-27 |
| K232558 | UroLift 2 ATC Advanced Tissue Control System | Neotract, Inc. | PEW | Class II | 2023-09-22 |
| K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | FGE | Class II | 2023-09-21 |
| K230767 | Pelvic Floor Muscle Stimulator | Nanjing Vishee Medical Technology Co., Ltd. | KPI | Class II | 2023-09-21 |
| K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | KDN | Class II | 2023-09-21 |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | Stryker | OWN | Class II | 2023-09-20 |
| K230692 | TULSA-PRO System | Profound Medical, Inc. | PLP | Class II | 2023-09-20 |
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. | QTD | Class II | 2023-09-18 |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation | FED | Class II | 2023-09-15 |
| K230332 | Ambu® aScope Colon; Ambu® aBox 2 | Ambu A/S | FDF | Class II | 2023-09-15 |
| K230526 | TEA Device | Transtimulation Research, Inc. | QHH | Class II | 2023-09-14 |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | KDI | Class II | 2023-09-14 |
| K230598 | Stone Extraction Baskets | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | LQR | Class II | 2023-09-12 |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | OCX | Class II | 2023-09-08 |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | FDF | Class II | 2023-09-08 |
| K231240 | MaxTack Motorized Fixation Device | Covidien | OCW | Class II | 2023-09-08 |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | FGE | Class II | 2023-09-06 |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | FDS | Class II | 2023-09-01 |
| K231323 | Ancora-SB | Aspero Medical, Inc. | FDA | Class II | 2023-08-31 |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | FFK | Class II | 2023-08-31 |
| K213271 | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | OCW | Class II | 2023-08-31 |
| K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | PLQ | Class II | 2023-08-30 |
| K231422 | Precision GI | Limaca Medical, Ltd. | FCG | Class II | 2023-08-28 |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) | Coloplast | EZD | Class II | 2023-08-25 |
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Stryker Corporation | GCJ | Class II | 2023-08-18 |
| K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. | KPM | Class II | 2023-08-18 |
| DEN230019 | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) | Boston Scientific Corporation | QXH | Class II | 2023-08-18 |
| K230588 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | FDF | Class II | 2023-08-17 |
| K222772 | Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. | PNR | Class II | 2023-08-17 |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | PIF | Class II | 2023-08-17 |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | FIP | Class II | 2023-08-16 |
| DEN220073 | Revi System | Bluewind Medical , Ltd. | QXM | Class II | 2023-08-16 |
| K223874 | BAROguard | Paragonix Technologies | KDN | Class II | 2023-08-15 |
| K231418 | ENDOGATOR Hybrid Irrigation Tubing | Medivators | OCX | Class II | 2023-08-14 |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | Boston Scientific Corporation | KNS | Class II | 2023-08-14 |
| K230632 | VersiHD with GuideMe software | Nxstage Medical, Inc. | KDI | Class II | 2023-08-11 |
| K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | KPO | Class II | 2023-08-04 |
| K231400 | Bladeless Trocar Artemis Lap Cannula | T.A.G. Medical Products Corporation, Ltd. | GCJ | Class II | 2023-08-04 |
| K231344 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | OWN | Class II | 2023-08-02 |
| K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | FED | Class II | 2023-08-02 |
| K223821 | Self-Cath Closed System | Coloplast | FCM | Class II | 2023-08-02 |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | Ga Health Company Limited | OCX | Class II | 2023-08-01 |
| K230004 | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | PKL | Class II | 2023-07-31 |
| K223097 | RenaNav Ureteroscope System | CenterPoint Systems, LLC | FGB | Class II | 2023-07-31 |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | Pentax of America, Inc. | PEA | Class II | 2023-07-28 |
| K230801 | Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc. | FED | Class II | 2023-07-28 |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | NIKKISO CO., LTD. | KOC | Class II | 2023-07-28 |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | EZL | Class II | 2023-07-27 |
| K231878 | 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 | 2023-07-25 |
| K223473 | ME-APDS; MAGENTIQ-COLO | Magentiq Eye, Ltd. | QNP | Class II | 2023-07-25 |
| K231861 | EndoflipTM 300 System | Covidien, LLC | FFX | Class II | 2023-07-21 |
| K230560 | enspire 300 Series Automated Endoscope Reprocessor System | STERIS Corporation | NZA | Class II | 2023-07-21 |
| K231410 | RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies, LLC | FIP | Class II | 2023-07-19 |
| K230407 | FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | OWN | Class II | 2023-07-17 |
| K223683 | EnteraLoc Flow | Vonco Products | PIF | Class II | 2023-07-10 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.