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
K896310Substantially Equivalent

Acufex Fixation Button; Retention Bar, Wedge

Acufex Microsurgical, Inc., Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896310 is the FDA 510(k) clearance record for ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE, a class I device, cleared for Acufex Microsurgical, Inc. on under FDA product code KGS (Retention Device, Suture). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show no recalls naming K896310.

Clearance record

Decision date
Received
(19 days to decision)
Product code
KGS Retention Device, Suture
Regulation
21 CFR 878.4930
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Acufex Microsurgical, Inc. 575 University Ave., Norwood MA
Third party review
No

Clearances, product code KGS

Trailing 12 months

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

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