# Karl Storz SE & CO. KG

- Location (FDA's records): Tuttlingen, DE
- FDA decisions: 34 (2018–2026): 34 510(k) clearances
- Names in FDA's records: Karl Storz SE & CO. KG (33); KARL STORZ SE & CO. KG (1)
- Product codes: OWN (4), FGB (4), HIG (3), GCJ (3), HIF (2), EOB (2), FBO (2), HIH (2), FJL (1), ODA (1), GEX (1), FGA (1)
- 510(k) review time since 2016: median 193 days, against 147 for FDA's reviews in the same codes and years (6 of 23 faster)
- Predicates its devices cite: 49 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- KARL STORZ Endoscopy-America, Inc.: 26 (https://510kreport.com/company/karl-storz-endoscopy-america)
- W.O.M. World of Medicine GmbH: 4 (https://510kreport.com/company/wom-world-of-medicine)
- Karl Storz Endoscopy: 2 (https://510kreport.com/company/karl-storz-endoscopy)
- Karl Storz Endoskop GmbH: 2 (https://510kreport.com/company/karl-storz-endoskop)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Applied Medical: 1 (https://510kreport.com/company/applied-medical)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Novadaq Technologies Ulc (A Part of Stryker): 1 (https://510kreport.com/company/novadaq-technologies-ulc-a-part-of-stryker)

## Its most-cited devices
- K233333: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (2023), cited by 2
- K250388: Endoflator + (2025), cited by 1
- K180735: Endomat Select (2018), cited by 1
- K233372: KARL STORZ Fiber Telescopes for Urology (2024), cited by 1
- K201355: Endomat Select, IBS Shaver Software, License (2020), cited by 1
- K241945: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) (2024), cited by 1

## Recent decisions
- K260581: KARL STORZ Flexible Video Neuro-Endoscope (Oct 14, 2026)
- K254252: UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (Sep 25, 2026)
- K254303: Karl Storz Supraloop (Sep 24, 2026)
- K261102: UNIDRIVE Select System (Sep 18, 2026)
- K254299: CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (Sep 15, 2026)
- K260884: UNIDRIVE Select System (Sep 1, 2026)
- K254103: HOPKINS Telescopes for Arthroscopy (Aug 26, 2026)
- K260209: ENDOFLATOR+; Smart Smoke Evacuation (Aug 19, 2026)

Source page: https://510kreport.com/company/karl-storz