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FDA 510(k)

ACUFEX ENDOBUTTON SYSTEM

K-Number: K933948 · 1994-07-21

ApplicantAcufex Microsurgical, Inc.
Decision Date1994-07-21
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX ENDOBUTTON SYSTEM 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 1994-07-21 under 510(k) number K933948. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX ENDOBUTTON SYSTEM?

ACUFEX ENDOBUTTON SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-21. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K933948.

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

ACUFEX ENDOBUTTON SYSTEM received FDA 510(k) clearance on 1994-07-21, under 510(k) number K933948.

Who is the listed applicant for ACUFEX ENDOBUTTON SYSTEM?

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 SYSTEM?

The FDA product code for ACUFEX ENDOBUTTON SYSTEM is MAI.

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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

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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