510(k) clearance

Mediclose Cartridge System

FDA 510(k) source

510(k) number

K262044

Applicant

Health Value Creation B.V. (trading as Corporis Medical)

Decision date

Oct 14, 2026

Date received

Jun 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OCW

Device type

Endoscopic Tissue Approximation Device

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Maastricht, NL