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FDA 510(k)

ACUFEX FIXATION POST

K-Number: K924514 · 1992-10-13

ApplicantAcufex Microsurgical, Inc.
Decision Date1992-10-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX FIXATION POST 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 1992-10-13 under 510(k) number K924514. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX FIXATION POST?

ACUFEX FIXATION POST is a medical device that received FDA 510(k) clearance on 1992-10-13. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K924514.

When did ACUFEX FIXATION POST receive FDA 510(k) clearance?

ACUFEX FIXATION POST received FDA 510(k) clearance on 1992-10-13, under 510(k) number K924514.

Who is the listed applicant for ACUFEX FIXATION POST?

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 FIXATION POST?

The FDA product code for ACUFEX FIXATION POST is HWC. This falls under the Cardiovascular category.

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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 SYSTEMK953459ACUFEX TAG ANCHOR

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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