510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964016Substantially Equivalent for Some Indications

Tielle Hydropolymer Foam Dressing

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

K964016 is the FDA 510(k) clearance record for TIELLE HYDROPOLYMER FOAM DRESSING, a class I device, cleared for Johnson & Johnson Medical, Inc. on under FDA product code KMF (Bandage, Liquid). FDA records list 56 510(k) clearances for Johnson & Johnson Medical, Inc., from to . As of , FDA records show no recalls naming K964016.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Johnson & Johnson Medical, Inc. 2500 Arbrook Blvd., Arlington TX
Third party review
No

Clearances, product code KMF

Trailing 12 months

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

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