ACUFEX ENDOBUTTON SYSTEM— 510(k) K933948

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K933948 for ACUFEX ENDOBUTTON SYSTEM, Substantially Equivalent on 1994-07-21. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1993-08-12
Decision date: 1994-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.