510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K955863Substantially Equivalent for Some Indications

Alldress Multi Layered Wound Dressing

Molnlycke/Scott Health Care, Fort Worth TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K955863 is the FDA 510(k) clearance record for ALLDRESS MULTI LAYERED WOUND DRESSING, a class I device, cleared for Molnlycke/Scott Health Care on under FDA product code NAD (Dressing, Wound, Occlusive). FDA records list one 510(k) clearance for Molnlycke/Scott Health Care. As of , FDA records show no recalls naming K955863.

Clearance record

Decision date
Received
(77 days to decision)
Product code
NAD Dressing, Wound, Occlusive
Regulation
21 CFR 878.4020
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Molnlycke/Scott Health Care 100 E. 15th St.,Suite 320, Fort Worth TX
Third party review
No

Clearances, product code NAD

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