510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952535Substantially Equivalent for Some Indications

Acufex Endobutton Tape

Acufex Microsurgical, Inc., Mansfield MA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K952535 is the FDA 510(k) clearance record for ACUFEX ENDOBUTTON TAPE, a class II device, cleared for Acufex Microsurgical, Inc. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show 2 recalls naming K952535.

Clearance record

Decision date
Received
(252 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Acufex Microsurgical, Inc. 130 Forbes Blvd., Mansfield MA
Third party review
No

Clearances, product code GAT

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