KARL STORZ Trocars with Valve Seals— 510(k) K254228
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K254228 for KARL STORZ Trocars with Valve Seals, Substantially Equivalent on 2026-05-11. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
Karl Storz SE & Co. KG filed KARL STORZ Trocars with Valve Seals under GCJ, general and plastic surgery laparoscopes.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
The record lists the location as Tuttlingen, with state code DE and country code US. The decision came 136 calendar days after receipt (December 26, 2025 to May 11, 2026).
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE, US
Recent devices under product code GCJ
view allMore clearances from Karl Storz SE & CO. KG
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.