ACUMED SUTURE WASHER— 510(k) K965028

Substantially Equivalent

Acu Med, Inc.

FDA 510(k) clearance K965028 for ACUMED SUTURE WASHER, Substantially Equivalent on 1997-03-17. Applicant: Acu Med, Inc..

Clearance details

Applicant: Acu Med, Inc.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 1996-12-17
Decision date: 1997-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.