Cleared Traditional

Tissue Approximation System (TAS)

K220980 · Tas Medical, Inc. · General & Plastic Surgery

Jul 2023

Decision

457d

Days

Class 2

Risk

About This 510(k) Submission

K220980 is an FDA 510(k) clearance for the Tissue Approximation System (TAS), a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Tas Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on July 5, 2023, 457 days after receiving the submission on April 4, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.

Submission Details

510(k) Number	K220980 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2022
Decision Date	July 05, 2023
Days to Decision	457 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF