ACUFEX SHOULDER HOLDER— 510(k) K841388

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K841388 for ACUFEX SHOULDER HOLDER, Substantially Equivalent on 1984-05-16. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HST
Advisory panel: Orthopedic
Date received: 1984-04-03
Decision date: 1984-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code HST

product code HST

Other: 1
Total: 1

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.