510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894205Substantially Equivalent

Tecnol Silk Strip

Tecnol New Jersey Wound Care, Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894205 is the FDA 510(k) clearance record for TECNOL SILK STRIP, a class I device, cleared for Tecnol New Jersey Wound Care, Inc. on under FDA product code FPX (Strip, Adhesive, Closure, Skin). FDA records list 35 510(k) clearances for Tecnol New Jersey Wound Care, Inc., from to . As of , FDA records show no recalls naming K894205.

Clearance record

Decision date
Received
(36 days to decision)
Product code
FPX Strip, Adhesive, Closure, Skin
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Tecnol New Jersey Wound Care, Inc. 7201 Industrial Park Blvd., Fort Worth TX
Third party review
No

Clearances, product code FPX

Trailing 12 months

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

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