510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933948Substantially Equivalent

Acufex Endobutton System

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

K933948 is the FDA 510(k) clearance record for ACUFEX ENDOBUTTON SYSTEM, a class II device, cleared for Acufex Microsurgical, Inc. on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show no recalls naming K933948.

Clearance record

Decision date
Received
(343 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Acufex Microsurgical, Inc. 130 Forbes Blvd., Mansfield MA
510(k) summary
Statement
Third party review
No

Clearances, product code MAI

Trailing 12 months
5 clearances under product code MAI in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260