Anika Tissue Tack Fixation System— 510(k) K222487

Name: FDA 510(k) clearance K222487
Creator: U.S. Food and Drug Administration
Published: 2023-05-08

Substantially Equivalent

Anika Therapeutics, Inc.

FDA 510(k) clearance K222487 for Anika Tissue Tack Fixation System, Substantially Equivalent on 2023-05-08. Applicant: Anika Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Anika Therapeutics, Inc.
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2022-08-17
Decision date: 2023-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beford, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.