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FDA 510(k)

ACUFEX TAG ANCHOR

K-Number: K953459 · 1995-08-23

ApplicantAcufex Microsurgical, Inc.
Decision Date1995-08-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX TAG ANCHOR 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 1995-08-23 under 510(k) number K953459. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX TAG ANCHOR?

ACUFEX TAG ANCHOR is a medical device that received FDA 510(k) clearance on 1995-08-23. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K953459.

When did ACUFEX TAG ANCHOR receive FDA 510(k) clearance?

ACUFEX TAG ANCHOR received FDA 510(k) clearance on 1995-08-23, under 510(k) number K953459.

Who is the listed applicant for ACUFEX TAG ANCHOR?

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 TAG ANCHOR?

The FDA product code for ACUFEX TAG ANCHOR is MBI.

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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 SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK941740ACUFEX ROTATOR CUFF FIXATION BUTTON

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Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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