510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901853Substantially Equivalent

Modified Labeling for Bioclusive* Trans Film Dress

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

K901853 is the FDA 510(k) clearance record for MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS, a class I device, cleared for Johnson & Johnson Medical, Inc. on under FDA product code NAD (Dressing, Wound, Occlusive). FDA records list 56 510(k) clearances for Johnson & Johnson Medical, Inc., from to . As of , FDA records show no recalls naming K901853.

Clearance record

Decision date
Received
(279 days to decision)
Product code
NAD Dressing, Wound, Occlusive
Regulation
21 CFR 878.4020
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Johnson & Johnson Medical, Inc. P.O. Box 90130, Arlington TX
Third party review
No

Clearances, product code NAD

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