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FDA 510(k)

SMARTSTITCH PERFECTPASSER SYSTEM

K-Number: K123268 · 2012-11-07

ApplicantArthocare Corporation
Decision Date2012-11-07
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTSTITCH PERFECTPASSER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthocare Corporation. It received FDA 510(k) clearance on 2012-11-07 under 510(k) number K123268. 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 SMARTSTITCH PERFECTPASSER SYSTEM?

SMARTSTITCH PERFECTPASSER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-07. The listed applicant is Arthocare Corporation. The 510(k) number is K123268.

When did SMARTSTITCH PERFECTPASSER SYSTEM receive FDA 510(k) clearance?

SMARTSTITCH PERFECTPASSER SYSTEM received FDA 510(k) clearance on 2012-11-07, under 510(k) number K123268.

Who is the listed applicant for SMARTSTITCH PERFECTPASSER SYSTEM?

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

What is the FDA product code for SMARTSTITCH PERFECTPASSER SYSTEM?

The FDA product code for SMARTSTITCH PERFECTPASSER SYSTEM is GAT.

Related Clinical Trials

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Other records listing Arthocare Corporation 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.

K153669MultiFIX S Ultra Knotless Fixation SystemK131182MULTIFIX S KNOTLESS FIXATION DEVICEK120791AMBIENT TURBOFLASH 90 IFSK121306SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLEK013334ENDOFLIP

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.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.

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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