510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K261338Substantially Equivalent

RENASYS DYNAFLOW Kit (66807741)

Smith & Nephew Medical, Ltd., Hull, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(141 days to decision)
Product code
OMP Negative Pressure Wound Therapy Powered Suction Pump
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Smith & Nephew Medical, Ltd. 101 Hessle Rd., Hull, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMP

Trailing 12 months
8 clearances under product code OMP in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OMP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20263
June 20262
July 20260
August 20260
September 20261
October 20260