ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE— 510(k) K940480

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K940480 for ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE, Substantially Equivalent on 1994-03-23. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HTJ
Advisory panel: Orthopedic
Date received: 1994-02-02
Decision date: 1994-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code HTJ

product code HTJ

Malfunction: 2,320
Total: 2,320

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.