510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061554Substantially Equivalent

Mepilex Ag Absorbent Silicone-Coated Dressing

Molnlycke Health Care, Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061554 is the FDA 510(k) clearance record for MEPILEX AG ABSORBENT SILICONE-COATED DRESSING, cleared for Molnlycke Health Care on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 19 510(k) clearances for Molnlycke Health Care, from to . As of , FDA records show no recalls naming K061554.

Clearance record

Decision date
Received
(234 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Molnlycke Health Care 5550 Peachtree Pkwy., Suite 500, Norcross GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260