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FDA 510(k)

Tissue Approximation System

K-Number: K261484 · 2026-06-03

ApplicantTas Medical, Inc.
Decision Date2026-06-03
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tissue Approximation System is the device name listed in this FDA 510(k) record. The listed applicant is Tas Medical, Inc.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K261484. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tissue Approximation System?

Tissue Approximation System is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Tas Medical, Inc.. The 510(k) number is K261484.

When did Tissue Approximation System receive FDA 510(k) clearance?

Tissue Approximation System received FDA 510(k) clearance on 2026-06-03, under 510(k) number K261484.

Who is the listed applicant for Tissue Approximation System?

The FDA 510(k) record lists Tas Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tissue Approximation System?

The FDA product code for Tissue Approximation System is GAR.

Other records listing Tas Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220980Tissue Approximation System (TAS)

Related Devices (Code: GAR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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