510(k) clearance

RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)

FDA 510(k) source

510(k) number

K261982

Applicant

Smith & Nephew Medical, Ltd.

Decision date

Oct 23, 2026

Date received

Jun 12, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OMP

Device type

Negative Pressure Wound Therapy Powered Suction Pump

Device class

Class II

Regulation

21 CFR 878.4780

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Kingston Upon Hull, GB