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FDA 510(k)

ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA

K-Number: K942834 · 1994-09-28

ApplicantAcufex Microsurgical, Inc.
Decision Date1994-09-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA 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 1994-09-28 under 510(k) number K942834. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA?

ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K942834.

When did ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA receive FDA 510(k) clearance?

ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA received FDA 510(k) clearance on 1994-09-28, under 510(k) number K942834.

Who is the listed applicant for ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA?

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 UNI-CUT 4. OMM CARPAL TUNNEL CANNULA?

The FDA product code for ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA is HRX.

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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.

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Related Devices (Code: HRX)

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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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