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Panels › Gastroenterology, Urology › Product code OWN · Class 2

Confocal Optical Imaging

Regulation 876.1500

8510(k)s in 12 months (63 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in OWN

Company510(k)sRecalls
Mauna Kea Technologies160
Visionsense, Ltd.43
KARL STORZ Endoscopy-America, Inc.60
Stryker60
Karl Storz SE & CO. KG40
Novadaq Technologies Ulc. (Now A Part of Stryker)40
Activ Surgical, Inc.20
Medtronic20
Olympus Medical Systems Corp.20
SmartsurgN, Inc.20
Decided510(k)Device and applicantCode
Sep 21, 2026K262547KARL STORZ TIPCAM1 Rubina
KALR STORZ SE & Co. KG, DE
OWN
Jul 24, 2026K254180PerfusiX-Imaging
LIMIS Development B.V., NL
OWN
Apr 20, 2026K242163SmartSurgN Visualization System
SmartsurgN, Inc.
OWN
Feb 26, 2026K254242KARL STORZ ICG Imaging System with RUBINA® Lens
Karl Storz SE & CO. KG, DE
OWN
Feb 13, 2026K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
VPIX Medical, Inc., KR
OWN
Feb 12, 2026K260108L12 LED Light Source with AIM
Stryker Endoscopy
OWN
Feb 12, 2026K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)
Karl Storz SE & CO. KG, DE
OWN
Nov 12, 2025K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S7
Olympus Medical Systems Corp., JP
OWN
Jul 24, 2025K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Im
Wuxi Hisky Medical Technologies Co., Ltd., CN
OWN
Feb 19, 2025K243591OPTOVISION Endoscopic Light Source Unit
Optosurgical, LLC
OWN
Aug 19, 2024K241275Histolog® Scanner (Hardware 2.4, Software 3.3)
Samantree Medical SA, CH
OWN
Nov 21, 2023K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
Karl Storz SE & CO. KG, DE
OWN
Nov 6, 2023K232857KARL STORZ ICG Imaging System
Karl Storz SE & CO. KG, DE
OWN
Sep 20, 2023K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
Stryker
OWN
Aug 2, 2023K231344ActivSight Intraoperative Imaging System
Activ Surgical, Inc.
OWN
Jul 17, 2023K230407FloNavi Open Field Fluorescence Imaging System
Guangdong Optomedic Technologies, Inc., CN
OWN
Apr 11, 2023K230754L12 LED Light Source with AIM
Stryker
OWN
Nov 29, 2022K213943SmartSurgN Visualization System
Smartsurgn Incorporated
OWN
Oct 28, 2022K223020VS3-Iridium System (VS3-IR)
Visionsense, Ltd., IL
OWN
Jun 29, 2022K221611780 nm L11 LED Light Source with AIM
Stryker
OWN
Apr 11, 2022K220477Cellvizio 100 series system with confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Nov 22, 2021K210265VS3 Iridium Sytem
Visionsense, Ltd., IL
OWN
Nov 15, 2021K212695KARL STORZ ICG Imaging System
Karl Storz Endoscopy America
OWN
Aug 18, 2021K212322Cellvizio I.V.E. system with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Apr 8, 2021K203550ActivSight Intraoperative Imaging System
Activ Surgical, Inc.
OWN
Dec 17, 2020K202925KARL STORZ ICG Imaging System
Karl Storz Endoscopy_America, Inc.
OWN
Nov 5, 2020K202244SPY-PHI System with SPY-PHI Fluorescence Assessment Software
Novadaq Technologies Ulc. (Now A Part of Stryker), CA
OWN
Aug 17, 2020K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 4
Karl Storz-Endoscopy-America, Inc.
OWN
Jul 17, 2020K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclav
Olympus Medical Systems Corp., JP
OWN
May 21, 2020K200737SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies Ulc. (Now A Part of Stryker), CA
OWN
Feb 28, 2020K193416Cellvizio I.V.E. with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Jan 24, 2020K191144Cellvizio 100 Series System with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Nov 25, 2019K191851VS3-IR
Medtronic, IL
OWN
Nov 19, 2019K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
Stryker
OWN
Nov 15, 2019K192174SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies Ulc. (Now A Part of Stryker), CA
OWN
May 10, 2019K191046L10 LED Light Source with AIM, L11 LED Light Source with AIM
Stryker
OWN
Apr 19, 2019K190729SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies Ulc. (Now A Part of Stryker), CA
OWN
Mar 4, 2019K183453VS3-IR
Medtronic, IL
OWN
Feb 22, 2019K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Jan 18, 2018K173866Stryker AIM Light Source and SafeLight cable
Stryker
OWN
Dec 15, 2017K172844Cellvizio 100 Series System with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Aug 4, 2017K171345Cellvizio 100 Series Systems with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
May 25, 2017K171238KARL STORZ ICG Imaging System
KARL STORZ Endoscopy-America, Inc.
OWN
Jan 26, 2017K162882KARL STORZ ICG Imaging System
KARL STORZ Endoscopy-America, Inc.
OWN
Jan 11, 2017K162885SPY Phi Open Field Handheld Fluorescence Imaging System
Novadaq Technologies, Inc., CA
OWN
May 31, 2016K152583KARL STORZ Endoscopic ICG Imaging System
KARL STORZ Endoscopy-America, Inc.
OWN
May 20, 2016K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Dec 22, 2015K150831Cellvizio 100 Series System with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN
Oct 28, 2015K152204VS3-IR system
Visionsense, Ltd., IL
OWN
Oct 23, 2015K151593Cellvizio 100 Series System with Confocal Miniprobes
Mauna Kea Technologies, FR
OWN

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