510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K943871Substantially Equivalent

Aquaplast Tie Down Dressing

Anholt Technologies Inc., Wyckoff NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943871 is the FDA 510(k) clearance record for AQUAPLAST TIE DOWN DRESSING, a class I device, cleared for Wfr/Aquaplast Corp. on under FDA product code LZM (Guard, Skin Graft). FDA records list 8 510(k) clearances for Anholt Technologies Inc., from to . As of , FDA records show no recalls naming K943871.

Clearance record

Decision date
Received
(53 days to decision)
Product code
LZM Guard, Skin Graft
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Wfr/Aquaplast Corp. P.O. Box 635, Wyckoff NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LZM

Trailing 12 months

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

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