ACUFEX DREZ COMMUNICATING DRILL GUIDE— 510(k) K834350

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K834350 for ACUFEX DREZ COMMUNICATING DRILL GUIDE, Substantially Equivalent on 1984-03-19. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code FZX
Advisory panel: General, Plastic Surgery
Date received: 1983-12-13
Decision date: 1984-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.