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FDA 510(k)

ACUFEX TAG DELIVERY SYSTEM

K-Number: K953276 · 1995-10-05

ApplicantAcufex Microsurgical, Inc.
Decision Date1995-10-05
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX TAG DELIVERY 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 1995-10-05 under 510(k) number K953276. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX TAG DELIVERY SYSTEM?

ACUFEX TAG DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K953276.

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

ACUFEX TAG DELIVERY SYSTEM received FDA 510(k) clearance on 1995-10-05, under 510(k) number K953276.

Who is the listed applicant for ACUFEX TAG DELIVERY 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 TAG DELIVERY SYSTEM?

The FDA product code for ACUFEX TAG DELIVERY SYSTEM is JDR.

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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 TAPEK953459ACUFEX TAG ANCHORK941740ACUFEX ROTATOR CUFF FIXATION BUTTON

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Related Devices (Code: JDR)

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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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