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FDA 510(k)

ACUFEX ENDOBUTTON TAPE

K-Number: K952535 · 1996-02-08

ApplicantAcufex Microsurgical, Inc.
Decision Date1996-02-08
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

ACUFEX ENDOBUTTON TAPE is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K952535. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ACUFEX ENDOBUTTON TAPE?

ACUFEX ENDOBUTTON TAPE is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K952535.

When did ACUFEX ENDOBUTTON TAPE receive FDA 510(k) clearance?

ACUFEX ENDOBUTTON TAPE received FDA 510(k) clearance on 1996-02-08, under 510(k) number K952535.

Who is the listed applicant for ACUFEX ENDOBUTTON TAPE?

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

What is the FDA product code for ACUFEX ENDOBUTTON TAPE?

The FDA product code for ACUFEX ENDOBUTTON TAPE is GAT.

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Other records listing Acufex Microsurgical, 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHORK941740ACUFEX ROTATOR CUFF FIXATION BUTTON

View all 78 devices →

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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