FDA Product Code
FDA Product Code OWN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 63 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262547 | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | 2026-09-21 | Traditional | PDF ↗ |
| K254180 | PerfusiX-Imaging | LIMIS Development B.V. | 2026-07-24 | Traditional | PDF ↗ |
| K242163 | SmartSurgN Visualization System | SmartsurgN, Inc. | 2026-04-20 | Traditional | PDF ↗ |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026-02-26 | Traditional | PDF ↗ |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. | 2026-02-13 | Traditional | PDF ↗ |
| K260108 | L12 LED Light Source with AIM | Stryker Endoscopy | 2026-02-12 | Special | PDF ↗ |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | 2026-02-12 | Traditional | PDF ↗ |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Olympus Medical Systems Corp. | 2025-11-12 | Traditional | PDF ↗ |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-07-24 | Traditional | PDF ↗ |
| K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | 2025-02-19 | Traditional | PDF ↗ |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA | 2024-08-19 | Traditional | PDF ↗ |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | 2023-11-21 | Traditional | PDF ↗ |
| K232857 | KARL STORZ ICG Imaging System | Karl Storz SE & CO. KG | 2023-11-06 | Traditional | PDF ↗ |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | Stryker | 2023-09-20 | Traditional | PDF ↗ |
| K231344 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | 2023-08-02 | Traditional | PDF ↗ |
| K230407 | FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | 2023-07-17 | Traditional | PDF ↗ |
| K230754 | L12 LED Light Source with AIM | Stryker | 2023-04-11 | Special | PDF ↗ |
| K213943 | SmartSurgN Visualization System | Smartsurgn Incorporated | 2022-11-29 | Traditional | PDF ↗ |
| K223020 | VS3-Iridium System (VS3-IR) | Visionsense, Ltd. | 2022-10-28 | Special | PDF ↗ |
| K221611 | 780 nm L11 LED Light Source with AIM | Stryker | 2022-06-29 | Special | PDF ↗ |
| K220477 | Cellvizio 100 series system with confocal Miniprobes | Mauna Kea Technologies | 2022-04-11 | Traditional | PDF ↗ |
| K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | 2021-11-22 | Traditional | PDF ↗ |
| K212695 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America | 2021-11-15 | Traditional | PDF ↗ |
| K212322 | Cellvizio I.V.E. system with Confocal Miniprobes | Mauna Kea Technologies | 2021-08-18 | Special | PDF ↗ |
| K203550 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | 2021-04-08 | Traditional | PDF ↗ |
| K202925 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy_America, Inc. | 2020-12-17 | Traditional | PDF ↗ |
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-11-05 | Traditional | PDF ↗ |
| K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head | Karl Storz-Endoscopy-America, Inc. | 2020-08-17 | Traditional | PDF ↗ |
| K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head | Olympus Medical Systems Corp. | 2020-07-17 | Traditional | PDF ↗ |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-05-21 | Traditional | PDF ↗ |
| K193416 | Cellvizio I.V.E. with Confocal Miniprobes | Mauna Kea Technologies | 2020-02-28 | Traditional | PDF ↗ |
| K191144 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2020-01-24 | Traditional | PDF ↗ |
| K191851 | VS3-IR | Medtronic | 2019-11-25 | Traditional | PDF ↗ |
| K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable | Stryker | 2019-11-19 | Traditional | PDF ↗ |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-11-15 | Traditional | PDF ↗ |
| K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIM | Stryker | 2019-05-10 | Special | PDF ↗ |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-04-19 | Special | PDF ↗ |
| K183453 | VS3-IR | Medtronic | 2019-03-04 | Traditional | PDF ↗ |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | Mauna Kea Technologies | 2019-02-22 | Special | PDF ↗ |
| K173866 | Stryker AIM Light Source and SafeLight cable | Stryker | 2018-01-18 | Special | PDF ↗ |
| K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2017-12-15 | Traditional | PDF ↗ |
| K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | 2017-08-04 | Traditional | PDF ↗ |
| K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017-05-25 | Special | PDF ↗ |
| K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017-01-26 | Traditional | PDF ↗ |
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | Novadaq Technologies, Inc. | 2017-01-11 | Traditional | PDF ↗ |
| K152583 | KARL STORZ Endoscopic ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2016-05-31 | Traditional | PDF ↗ |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes | Mauna Kea Technologies | 2016-05-20 | Special | PDF ↗ |
| K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015-12-22 | Traditional | PDF ↗ |
| K152204 | VS3-IR system | Visionsense, Ltd. | 2015-10-28 | Traditional | PDF ↗ |
| K151593 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015-10-23 | Traditional | PDF ↗ |
| K143474 | Artemis Hand Held Imaging System | Quest Medical Imaging | 2015-06-30 | Traditional | PDF ↗ |
| K150018 | VS3-IR-MMS System | Visionsense, Ltd. | 2015-06-17 | Traditional | PDF ↗ |
| K142310 | Stryker Infrared Fluorescence (IRF) Imaging System | Stryker Endoscopy | 2014-12-02 | Traditional | PDF ↗ |
| K141358 | CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES | Mauna Kea Technologies | 2014-09-25 | Traditional | PDF ↗ |
| K133466 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) | Mauna Kea Technologies | 2014-07-25 | Traditional | PDF ↗ |
| K132475 | FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM | Fluoptics | 2014-05-07 | Traditional | PDF ↗ |
| K132389 | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED | Daniel & Daniel Consulting | 2014-02-25 | Traditional | PDF ↗ |
| K124031 | DA VINCI FLUORESCENCE IMAGING VISION SYSTEM | Intuitive Surgical, Inc. | 2013-09-13 | Traditional | PDF ↗ |
| K123676 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | Mauna Kea Technologies | 2013-04-18 | Traditional | PDF ↗ |
| K122042 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | Mauna Kea Technologies | 2012-09-04 | Traditional | PDF ↗ |
| K120208 | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES | Mauna Kea Technologies | 2012-04-20 | Special | PDF ↗ |
| K110480 | PDE PHOTODYNAMIC EYE | Hamamatsu Photonics K.K. | 2012-01-13 | Traditional | PDF ↗ |
| K111047 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES | Mauna Kea Technologies, Inc. | 2011-08-08 | Special | PDF ↗ |
Product code OWN · Class II · Gastroenterology, Urology. Data: openFDA.