510(k) clearance

UNIDRIVE Select System

FDA 510(k) source

510(k) number

K260884

Applicant

Karl Storz SE & CO. KG

Decision date

Sep 1, 2026

Date received

Mar 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GCJ

Device type

Laparoscope, General & Plastic Surgery

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Tuttlingen, DE