Karl Storz SE & CO. KG - FDA 510(k) Cleared Devices
Recent clearances: KARL STORZ Endoscopic Accessories for Urology, KARL STORZ Trocars with Valve Seals, KARL STORZ Mediastinoscopes and Instruments
25
Total
25
Cleared
0
Denied
FDA 510(k) Regulatory Record - Karl Storz SE & CO. KG General & Plastic Surgery ✕
7 devices
Cleared
May 11, 2026
KARL STORZ Trocars with Valve Seals
General & Plastic Surgery
136d
Cleared
Feb 26, 2026
KARL STORZ ICG Imaging System with RUBINA® Lens
General & Plastic Surgery
59d
Cleared
Feb 12, 2026
IMAGE1 (TC400US)
General & Plastic Surgery
63d
Cleared
Nov 22, 2025
KARL STORZ Cholangiography Set
General & Plastic Surgery
239d
Cleared
Nov 21, 2023
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
General & Plastic Surgery
53d
Cleared
Nov 06, 2023
KARL STORZ ICG Imaging System
General & Plastic Surgery
52d
Cleared
Oct 03, 2023
KARL STORZ OR1™ SCB CONTROL (WU300)
General & Plastic Surgery
54d