510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K981713Substantially Equivalent

Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 in. Model0

Smith & Nephew, Inc., Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981713 is the FDA 510(k) clearance record for CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0, cleared for Smith & Nephew, Inc. on under FDA product code MGP (Dressing, Wound And Burn, Occlusive). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K981713.

Clearance record

Decision date
Received
(77 days to decision)
Product code
MGP Dressing, Wound And Burn, Occlusive
Device class
Unclassified
Review panel
Unknown
Applicant
Smith & Nephew, Inc. 11775 Starkey Rd., Largo FL
510(k) summary
Summary
Third party review
No

Clearances, product code MGP

Trailing 12 months

FDA records hold no clearances under product code MGP in the trailing twelve months.

FDA records show no clearances under product code MGP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260