510(k) K261484— Tissue Approximation System

Substantially Equivalent

Tas Medical, Inc.

Clearance details

Applicant: Tas Medical, Inc.
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 2026-05-05
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Windermere, FL, US

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.