Tissue Approximation System (TAS)— 510(k) K220980

Substantially Equivalent

Tas Medical, Inc.

FDA 510(k) clearance K220980 for Tissue Approximation System (TAS), Substantially Equivalent on 2023-07-05. Applicant: Tas Medical, Inc..

Clearance details

Applicant: Tas Medical, Inc.
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 2022-04-04
Decision date: 2023-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.