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FDA 510(k)

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

K-Number: K163142 · 2017-01-06

ApplicantArthroCare Corporation
Decision Date2017-01-06
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K163142. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader?

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is ArthroCare Corporation. The 510(k) number is K163142.

When did SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader receive FDA 510(k) clearance?

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163142.

Who is the listed applicant for SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader?

The FDA 510(k) record lists ArthroCare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader?

The FDA product code for SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader is GAT.

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Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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