510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250006Unknown

Amferia Wound Dressing

Amferia AB, Molndal, SE / Direct, Unknown
FDA source (opens on fda.gov)

DEN250006 is the FDA 510(k) clearance record for Amferia Wound Dressing, a class II device, cleared for Amferia AB on under FDA product code SHA (Solid Wound Dressing With Permanently Bound Antimicrobial Agent). FDA's definition for product code SHA reads: "A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to...". FDA records list one 510(k) clearance for Amferia AB. As of , FDA records show no recalls naming DEN250006.

Clearance record

Decision date
Received
(340 days to decision)
Product code
SHA Solid Wound Dressing With Permanently Bound Antimicrobial Agent
Regulation
21 CFR 878.4013
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Amferia AB C/O Az Bioventurehub Astra Zeneca, Molndal, SE
Third party review
No

Clearances, product code SHA

Trailing 12 months
1 clearance under product code SHA in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260