UNIDRIVE Select System— 510(k) K260884
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K260884 for UNIDRIVE Select System, Substantially Equivalent on 2026-09-01. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
UNIDRIVE Select System is a Karl Storz SE & CO. KG submission under product code GCJ (Laparoscope, General & Plastic Surgery). The record doesn't describe the system beyond its name and code.
Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Karl Storz filed from Tuttlingen, Germany. The decision came 168 calendar days after receipt (March 17 to September 1, 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
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.