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FDA 510(k)

Tissue Approximation System (TAS)

K-Number: K220980 · 2023-07-05

ApplicantTas Medical, Inc.
Decision Date2023-07-05
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tissue Approximation System (TAS) is a medical device manufactured by Tas Medical, Inc.. It received FDA 510(k) clearance on 2023-07-05 under approval number K220980. 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 (TAS)?

Tissue Approximation System (TAS) is a medical device that received FDA 510(k) clearance on 2023-07-05. It is manufactured by Tas Medical, Inc.. The 510(k) number is K220980.

When was Tissue Approximation System (TAS) approved by the FDA?

Tissue Approximation System (TAS) received FDA 510(k) clearance on 2023-07-05, under approval number K220980.

What company makes Tissue Approximation System (TAS)?

Tissue Approximation System (TAS) is manufactured by Tas Medical, Inc..

What is the FDA product code for Tissue Approximation System (TAS)?

The FDA product code for Tissue Approximation System (TAS) is GAR.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07278869 Applause Study I - Append System Early Feasibility Study RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 25938303 Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database. JAMA internal medicine (2015)

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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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