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FDA 510(k)

ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT

K-Number: K922557 · 1992-09-17

ApplicantAcufex Microsurgical, Inc.
Decision Date1992-09-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT 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 1992-09-17 under 510(k) number K922557. 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 ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT?

ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT is a medical device that received FDA 510(k) clearance on 1992-09-17. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K922557.

When did ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT receive FDA 510(k) clearance?

ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT received FDA 510(k) clearance on 1992-09-17, under 510(k) number K922557.

Who is the listed applicant for ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT?

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 ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT?

The FDA product code for ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT 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)

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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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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