FDA.report

510(k) K232857

Device
KARL STORZ ICG Imaging System
Applicant
Karl Storz SE & CO. KG
510(k) number
K232857
Product code
OWN
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-06
Date received
2023-09-15
Regulation
876.1500
Classification name
Confocal Optical Imaging
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Alita McElroy
Address
Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen DE 78532 78532

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OWN

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K260108L12 LED Light Source with AIMStryker Endoscopy2026-02-12
K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG2026-02-12
K251336VISERA 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
K243711Confocal 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
K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC2025-02-19
K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA2024-08-19
K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG2023-11-21
K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker2023-09-20
K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.2023-08-02
K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.2023-07-17
K230754L12 LED Light Source with AIMStryker2023-04-11
K213943SmartSurgN Visualization SystemSmartsurgn Incorporated2022-11-29