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

Name: FDA 510(k) clearance K220980
Creator: U.S. Food and Drug Administration
Published: 2023-07-05

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.. 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: 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 ↗

Recent devices under product code GAR

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K261484 — Tissue Approximation System2026-06-03
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 →

Recalls naming K220980

K-number listed on FDA's recall record

Z-1294-2025 — TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAPClass II·Ongoing·TAS Medical Inc·20250127

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220980.

Data sourced from openFDA. This site is unofficial and independent of the FDA.