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FDA 510(k)

ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE

K-Number: K940480 · 1994-03-23

ApplicantAcufex Microsurgical, Inc.
Decision Date1994-03-23
Product CodeHTJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX SUB-ACROMIAL SPACE 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 1994-03-23 under 510(k) number K940480. 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 SUB-ACROMIAL SPACE MEASURING DEVICE?

ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE is a medical device that received FDA 510(k) clearance on 1994-03-23. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K940480.

When did ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE receive FDA 510(k) clearance?

ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE received FDA 510(k) clearance on 1994-03-23, under 510(k) number K940480.

Who is the listed applicant for ACUFEX SUB-ACROMIAL SPACE 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 SUB-ACROMIAL SPACE MEASURING DEVICE?

The FDA product code for ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE is HTJ.

Related Clinical Trials

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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.

K925335ACUFEX INTRA ARTICULAR 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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