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FDA 510(k)

ACUFEX INTRA ARTICULAR MEASURING DEVICE

K-Number: K925335 · 1992-12-29

ApplicantAcufex Microsurgical, Inc.
Decision Date1992-12-29
Product CodeHTJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX INTRA ARTICULAR MEASURING DEVICE 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 1992-12-29 under 510(k) number K925335. The device is classified under product code HTJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX INTRA ARTICULAR MEASURING DEVICE?

ACUFEX INTRA ARTICULAR MEASURING DEVICE is a medical device that received FDA 510(k) clearance on 1992-12-29. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K925335.

When did ACUFEX INTRA ARTICULAR MEASURING DEVICE receive FDA 510(k) clearance?

ACUFEX INTRA ARTICULAR MEASURING DEVICE received FDA 510(k) clearance on 1992-12-29, under 510(k) number K925335.

Who is the listed applicant for ACUFEX INTRA ARTICULAR MEASURING DEVICE?

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 INTRA ARTICULAR MEASURING DEVICE?

The FDA product code for ACUFEX INTRA ARTICULAR MEASURING DEVICE is HTJ.

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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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Related Devices (Code: HTJ)

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.

K940480ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICEAcufex Microsurgical, Inc.K873191ACROMED INTERBODY DEPTH GAUGESBuckman Co., Inc.K864426RAYLOR(TM) DEPTH GAUGECedar 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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