510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971597Substantially Equivalent

Comfeel Purilon Gel,15g(3900)/comfeel Purilon Gel,25g(3903)

MEDLINE INDUSTRIES, LP - Northfield, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971597 is the FDA 510(k) clearance record for COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903), a class I device, cleared for Coloplast Corp. on under FDA product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K971597.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Regulation
21 CFR 878.4022
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Coloplast Corp. 6401 Meadows W. Dr., Fort Worth TX
510(k) summary
Summary
Third party review
No

Clearances, product code NAE

Trailing 12 months

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

FDA records show no clearances under product code NAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAE, 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 20260
October 20260