510(k) clearance

UNIDRIVE Select System

FDA 510(k) source

510(k) number

K261102

Applicant

Karl Storz SE & CO. KG

Decision date

Sep 18, 2026

Date received

Apr 3, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HIH

Device type

Hysteroscope (And Accessories)

Device class

Class II

Regulation

21 CFR 884.1690

Advisory committee

Obstetrics/Gynecology

Statement or summary

Summary

Third party

N

Location

Tuttlingen, DE