Tissue Approximation System— 510(k) K261484

Name: FDA 510(k) clearance K261484
Creator: U.S. Food and Drug Administration
Published: 2026-06-03

Substantially Equivalent

Tas Medical, Inc.

FDA 510(k) clearance K261484 for Tissue Approximation System, Substantially Equivalent on 2026-06-03. Applicant: Tas Medical, Inc.. Device class: 2.

Clearance details

Applicant: Tas Medical, Inc.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAR

view all

K220980 — Tissue Approximation System (TAS)2023-07-05
K212888 — Golnit Nylon Monofilament Suture2022-03-31
K212603 — Non Absorbable Surgical Nylon Suture2021-12-22
K192420 — Crownjun Nylon Suture2020-05-29
K161633 — REXLON, REXSIL2017-03-02

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.