FDA Product Code
FDA Product Code GCJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 1,430 records · page 2 of 15
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Stryker | 2023-02-23 | Special | PDF ↗ |
| K221861 | FloNavi Endoscopic Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | 2023-02-18 | Traditional | PDF ↗ |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH | Guangdong Optomedic Technologies, Inc. | 2023-02-02 | Traditional | PDF ↗ |
| K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023-01-18 | Traditional | PDF ↗ |
| K221252 | Scivita 4KINSIGHT ICG Imaging System | Scivita Medical Technology Co., Ltd. | 2023-01-13 | Traditional | PDF ↗ |
| K222011 | HandX Instrument - Monopolar Spatula | Human Xtensions , Ltd. | 2023-01-12 | Special | PDF ↗ |
| K221004 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2022-12-20 | Traditional | PDF ↗ |
| K222575 | HurriChem Device Kit | Thermasolutions, LLC | 2022-12-06 | Traditional | PDF ↗ |
| K212736 | Canady Flex RoboWrist | Us Medical Innovations, LLC | 2022-11-22 | Traditional | PDF ↗ |
| K222504 | H1 | Karl Storz Endoscopy America, Inc. | 2022-11-10 | Traditional | PDF ↗ |
| 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. | 2022-10-20 | Traditional | PDF ↗ |
| K222890 | RADIANCE ULTRA 32 4K ZEROWIRE DUO | Nds Surgical Imaging, LLC | 2022-10-19 | Special | PDF ↗ |
| K222079 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2022-10-11 | Traditional | PDF ↗ |
| K221533 | Plasma Shield | Plasmatica, Ltd. | 2022-09-12 | Traditional | PDF ↗ |
| K221365 | LapBox Tissue Containment Removal System | Ark Surgical, Ltd. | 2022-08-25 | Traditional | PDF ↗ |
| K222130 | 1688 4K Camera System with Advanced Imaging Modality | Stryker | 2022-08-19 | Special | PDF ↗ |
| K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | Covidien | 2022-06-27 | Traditional | PDF ↗ |
| K211148 | CORE-Trocar | Incore Co., Ltd. | 2022-06-21 | Traditional | PDF ↗ |
| K221217 | SPY Laparoscope | Stryker | 2022-06-17 | Traditional | PDF ↗ |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable | Stryker | 2022-05-25 | Traditional | PDF ↗ |
| K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) | Stryker | 2022-04-22 | Special | PDF ↗ |
| K220872 | Saberscope5 Laparoscope | Xenocor, Inc. | 2022-04-20 | Special | PDF ↗ |
| K211043 | Alexis Contained Extraction System | Applied Medical Resources Corporation | 2022-03-31 | Traditional | PDF ↗ |
| K213860 | ArthroFree Wireless Surgical Camera System | Lazurite Holdings, LLC | 2022-03-23 | Traditional | PDF ↗ |
| K220069 | 4K UHD LCD Monitor OEV321UH | Olympus Medical Systems Corp. | 2022-03-09 | Traditional | PDF ↗ |
| K220108 | SDC4K Information Management System with Device and Voice Control Package | Stryker Endoscopy | 2022-02-09 | Special | PDF ↗ |
| K212055 | Connected OR Hub with Device and Voice Control | Stryker Corporation | 2021-12-16 | Traditional | PDF ↗ |
| K212500 | ArtiSential Trocar | Livsmed, Inc. | 2021-12-03 | Traditional | PDF ↗ |
| K212950 | FUJIFILM Video Laparoscope EL-R740M30 | Fujifilm Corporaton | 2021-12-02 | Traditional | PDF ↗ |
| K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | 2021-11-05 | Traditional | PDF ↗ |
| K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) | Stryker | 2021-11-04 | Traditional | PDF ↗ |
| K211234 | RedEx | Advanced Surgical Concepts, Ltd. | 2021-09-17 | Traditional | PDF ↗ |
| K212214 | HandX | Human Xtensions , Ltd. | 2021-09-13 | Traditional | PDF ↗ |
| K210248 | Lab Bag with Fabric Pouch | Advanced Medical Design Co., Ltd. | 2021-07-30 | Traditional | PDF ↗ |
| K202582 | Arthrex SynergyID Endoscopic Imaging System | Arthrex, Inc. | 2021-07-22 | Traditional | PDF ↗ |
| K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | 2021-06-30 | Traditional | PDF ↗ |
| K202551 | Cor-Knot Micro | Lsi Solutions, Inc. | 2021-06-24 | Traditional | PDF ↗ |
| K211250 | VisionPort System | New View Surgical, Inc. | 2021-06-21 | Traditional | PDF ↗ |
| K210495 | Port Access System | Surgical Innovations Limited | 2021-06-18 | Traditional | PDF ↗ |
| K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes | Stryker | 2021-04-13 | Traditional | PDF ↗ |
| K210584 | SDC3 HD Information Management System with Wireless Device Control Capability | Stryker | 2021-03-18 | Special | PDF ↗ |
| K203255 | 4K UHD Laparoscope | Scivita Medical Technology Co., Ltd. | 2021-02-24 | Traditional | PDF ↗ |
| K202303 | CORE E3 Suction/irrigator | Conmed Corporation | 2021-02-19 | Traditional | PDF ↗ |
| K203603 | Monopolar Hook | Human Xtensions , Ltd. | 2021-02-01 | Traditional | PDF ↗ |
| K201526 | TIPCAM1 Rubina Video Endoscope System | Karl Storz Endoscopy America | 2020-11-20 | Traditional | PDF ↗ |
| K202931 | Disposable Trocar | Wuxi Shukang Medical Appliance Co., Ltd. | 2020-11-17 | Traditional | PDF ↗ |
| K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) | Stryker | 2020-10-08 | Special | PDF ↗ |
| K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020-09-04 | Traditional | PDF ↗ |
| K201805 | VersaOne Reusable Positioning Trocar System | Covidien | 2020-08-26 | Traditional | PDF ↗ |
| K202130 | FUJIFILM Video Laparoscope | Fujifilm Corporation | 2020-08-20 | Special | PDF ↗ |
| K201641 | Disposable Laparoscope Trocar | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-08-06 | Traditional | PDF ↗ |
| K192499 | Cyber Blade | SIDAM S.r.l. | 2020-07-31 | Traditional | PDF ↗ |
| K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | Stryker | 2020-07-28 | Traditional | PDF ↗ |
| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | Smith & Nephew | 2020-07-17 | Traditional | PDF ↗ |
| K201243 | Disposable Specimen Retrieval Bag | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-07-10 | Traditional | PDF ↗ |
| K193272 | GTK Trocars | Guangzhou T.K Medical Instrument Co., Ltd. | 2020-07-09 | Traditional | PDF ↗ |
| K201593 | Looking Glass 4K Integrated Visualization System | Conmed Corporation | 2020-07-08 | Special | PDF ↗ |
| K201151 | O-Mec 690 Series Laparoscopes | Omec Medical, Inc. | 2020-06-22 | Traditional | PDF ↗ |
| K200902 | ClickClean | Medeon Biodesign, Inc. | 2020-04-30 | Special | PDF ↗ |
| K191866 | GelPOINT Mini Advanced Access Platform | Applied Medical | 2020-04-29 | Traditional | PDF ↗ |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) | Dannik | 2020-04-21 | Traditional | PDF ↗ |
| K193161 | Pristine Scope | Pristine Surgical | 2020-04-21 | Traditional | PDF ↗ |
| K191930 | 7 mm Extended Length Endoscope | Maquet Cardiovascular, LLC | 2020-04-15 | Traditional | PDF ↗ |
| K200517 | Standard Trocar | Standard Bariatrics | 2020-04-09 | Traditional | PDF ↗ |
| K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | Olympus Medical Systems Corp. | 2020-04-03 | Traditional | PDF ↗ |
| K192300 | EnlightenVue Microendoscopy System | Enlightenvue, Inc. | 2020-03-20 | Traditional | PDF ↗ |
| K200310 | 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality | Stryker | 2020-03-06 | Special | PDF ↗ |
| K192918 | Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation | 2020-02-20 | Traditional | PDF ↗ |
| K200228 | ClearCam System | Clearcam, LLC | 2020-02-19 | Traditional | PDF ↗ |
| K193315 | Xenocor Articulating Xenoscope Laparoscope | Xenocor, Inc. | 2020-01-27 | Special | PDF ↗ |
| K191678 | IP Converter | Sony Electronics, Inc. | 2020-01-10 | Traditional | PDF ↗ |
| K193137 | EASYGRIP FLO-41 Precision MIS Delivery System | Baxter Healthcare Corportation | 2020-01-08 | Traditional | PDF ↗ |
| K192643 | Dannik Laparoscopic Suction Irrigation System | Dannik | 2019-11-19 | Traditional | PDF ↗ |
| K192891 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2019-11-07 | Special | PDF ↗ |
| K190029 | Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2019-09-26 | Traditional | PDF ↗ |
| K183675 | 3D Visualization System | Scivita Medical Technology Co., Ltd. | 2019-09-25 | Traditional | PDF ↗ |
| K192172 | Connected OR Hub with Device and Voice Control | Stryker | 2019-09-09 | Special | PDF ↗ |
| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head | Smith and Nephew, Inc. | 2019-08-23 | Traditional | PDF ↗ |
| K191295 | Percutaneous Introducer Needle | Progressive Medical, Inc. | 2019-08-06 | Traditional | PDF ↗ |
| K190645 | Arthrex NanoScope System | Arthrex, Inc. | 2019-07-05 | Traditional | PDF ↗ |
| K191043 | da Vinci Handheld Camera | Intuitive Surgical, Inc. | 2019-06-06 | Traditional | PDF ↗ |
| K190831 | E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2019-05-31 | Traditional | PDF ↗ |
| K190592 | YelloPort Elite Port Access System | Surgical Innovations Limited | 2019-04-29 | Traditional | PDF ↗ |
| K190788 | Disposable Standard Clamp | Standard Bariatrics | 2019-04-18 | Special | PDF ↗ |
| K181173 | ELMED Laparoscopic Instruments and Accessories | Elmed Incorporated | 2019-03-22 | Traditional | PDF ↗ |
| K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMed | Conmed Corporation | 2019-03-13 | Traditional | PDF ↗ |
| K183264 | Flex-THOR scope | KARL STORZ Endoscopy-America, Inc. | 2019-01-18 | Traditional | PDF ↗ |
| K182434 | LaparoGuard | Mariner Endosurgery, Inc. | 2018-12-13 | Traditional | PDF ↗ |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018-11-21 | Traditional | PDF ↗ |
| K173917 | neoClose PDS | Neosurgical, Ltd. | 2018-11-08 | Traditional | PDF ↗ |
| K181258 | ConnectedOR Hub with Device and Voice Control | Stryker | 2018-11-05 | Traditional | PDF ↗ |
| K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM | Stryker | 2018-11-05 | Traditional | PDF ↗ |
| K181608 | Disposable Standard Clamp | Standard Bariatrics | 2018-09-27 | Traditional | PDF ↗ |
| K182080 | Scope Antifogging System | Xodus Medical, Inc. | 2018-09-19 | Traditional | PDF ↗ |
| K173822 | Anchor Tissue Retrieval System by CONMED | Conmed Corporation | 2018-09-11 | Traditional | PDF ↗ |
| K182024 | Dissecting Balloon System | Applied Medical Resources Corp. | 2018-08-30 | Traditional | PDF ↗ |
| K181791 | SIMPLYSTRONG, SIMPLYEZEE | Genicon, Inc. | 2018-08-21 | Traditional | PDF ↗ |
| K181395 | Universal Cannula Seal (5-12 mm) | Intuitive Surgical, Inc. | 2018-07-27 | Traditional | PDF ↗ |
| K180977 | KARL STORZ New Generation Trocars | KARL STORZ Endoscopy-America, Inc. | 2018-07-18 | Traditional | PDF ↗ |
| K180836 | Genistrong | Genicon, Inc. | 2018-04-18 | Special | PDF ↗ |
Product code GCJ · Class II · Gastroenterology, Urology. Data: openFDA.