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FDA 510(k)

ACUFEX LINEAR/ROTARY INSTRUMENTS

K-Number: K940981 · 1994-05-16

ApplicantAcufex Microsurgical, Inc.
Decision Date1994-05-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX LINEAR/ROTARY INSTRUMENTS 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 1994-05-16 under 510(k) number K940981. 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 LINEAR/ROTARY INSTRUMENTS?

ACUFEX LINEAR/ROTARY INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K940981.

When did ACUFEX LINEAR/ROTARY INSTRUMENTS receive FDA 510(k) clearance?

ACUFEX LINEAR/ROTARY INSTRUMENTS received FDA 510(k) clearance on 1994-05-16, under 510(k) number K940981.

Who is the listed applicant for ACUFEX LINEAR/ROTARY INSTRUMENTS?

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 LINEAR/ROTARY INSTRUMENTS?

The FDA product code for ACUFEX LINEAR/ROTARY INSTRUMENTS is HRX.

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Other records listing Acufex Microsurgical, Inc. as applicant

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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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