Medical Device Manufacturer · DE , Tuttlingen

Karl Storz SE & CO. KG

23 submissions · 23 cleared · Since 2018
23
Total
23
Cleared
0
Denied

Karl Storz SE & CO. KG — FDA 510(k) Submissions

Karl Storz SE & CO. KG has submitted 23 FDA 510(k) premarket notifications since 2018, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Confocal Optical Imaging, Ureteroscope And Accessories, Flexible/rigid, Cystourethroscope, Insufflator, Hysteroscopic, Cystoscope And Accessories, Flexible/rigid . Use the specialty filter in the sidebar to narrow results.

23 devices
1–12 of 23
KARL STORZ Mediastinoscopes and Instruments
K260003 · EWY Mediastinoscope, Surgical · Ear, Nose, Throat
Mar 2026 59d
KARL STORZ ICG Imaging System with RUBINA? Lens
K254242 · OWN Confocal Optical Imaging · General & Plastic Surgery
Feb 2026 59d
IMAGE1 (TC400US); X-to-4U Adapter (TC040)
K253972 · OWN Confocal Optical Imaging · General & Plastic Surgery
Feb 2026 63d
KARL STORZ Flexible Intubation Video Endoscope ? Sterile (FIVE-S) (0916612)
K251731 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Dec 2025 182d
KARL STORZ Cholangiography Set
K250927 · GCJ Laparoscope, General &... · General & Plastic Surgery
Nov 2025 239d
Miniature Telescope for Urology (27033AA)
K253411 · FGB Ureteroscope And... · Gastroenterology & Urology
Nov 2025 49d
ENDOFLATOR +
K250388 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Sep 2025 223d
KARL STORZ HOPKINS Telescopes for Urology
K243653 · FAJ Cystoscope And... · Gastroenterology & Urology
Aug 2025 260d
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
K243550 · FGB Ureteroscope And... · Gastroenterology & Urology
Jun 2025 203d
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
K244001 · FBO Cystourethroscope · Gastroenterology & Urology
May 2025 127d
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
K243409 · FBO Cystourethroscope · Gastroenterology & Urology
Nov 2024 26d
KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
K241945 · FGB Ureteroscope And... · Gastroenterology & Urology
Aug 2024 29d
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