510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982597Substantially Equivalent

Fibrcol Plus Collagen Wound Dressing with Alginate

Johnson & Johnson MEDICAL GmbH, Arlington TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982597 is the FDA 510(k) clearance record for FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE, cleared for Johnson & Johnson Medical, Inc. on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list 56 510(k) clearances for Johnson & Johnson Medical, Inc., from to . As of , FDA records show no recalls naming K982597.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Johnson & Johnson Medical, Inc. 2500 Arbrook Blvd., Arlington TX
510(k) summary
Summary
Third party review
No

Clearances, product code KGN

Trailing 12 months
16 clearances under product code KGN in the twelve months to October 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code KGN, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20262
March 20261
April 20260
May 20261
June 20265
July 20261
August 20261
September 20261
October 20260