510(k) clearance

RENASYS DYNAFLOW Kit (66807741)

FDA 510(k) source

510(k) number

K261338

Applicant

Smith & Nephew Medical, Ltd.

Decision date

Sep 11, 2026

Date received

Apr 23, 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

Hull, GB