510(k) clearance

KARL STORZ SUPRALOOP

FDA 510(k) source

510(k) number

K254303

Applicant

Karl Storz SE & CO. KG

Decision date

Sep 24, 2026

Date received

Dec 31, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KNF

Device type

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Device class

Class II

Regulation

21 CFR 884.4160

Advisory committee

Obstetrics/Gynecology

Statement or summary

Summary

Third party

N

Location

Tuttlingen, DE, US