FDA 510(k)

ACUFLEX DISPOSABLE KNIVES

K-Number: K933921 · 1994-01-26

Decision Date1994-01-26

Product CodeHTS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACUFLEX DISPOSABLE KNIVES 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 1994-01-26 under 510(k) number K933921. The device is classified under product code HTS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFLEX DISPOSABLE KNIVES?

ACUFLEX DISPOSABLE KNIVES is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K933921.

When did ACUFLEX DISPOSABLE KNIVES receive FDA 510(k) clearance?

ACUFLEX DISPOSABLE KNIVES received FDA 510(k) clearance on 1994-01-26, under 510(k) number K933921.

Who is the listed applicant for ACUFLEX DISPOSABLE KNIVES?

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 ACUFLEX DISPOSABLE KNIVES?

The FDA product code for ACUFLEX DISPOSABLE KNIVES is HTS.

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Other records listing Acufex Microsurgical, Inc. as applicant

K961555ACUFEX TAG BIOABSORBABLE ANCHORS K961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER K954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW K952535ACUFEX ENDOBUTTON TAPE K953276ACUFEX TAG DELIVERY SYSTEM K953459ACUFEX TAG ANCHOR

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Related Devices (Code: HTS)

K930507CUSTOM ORTHOPAEDIC TRAYS (PACKS)Associated Medical Products Co.K882525SPINAL MICROKNIFEKarlin Technology, Inc.K873714BANANA KNIFE, DISPOSABLE #TM-1612Arthropedics, Inc.K873713TRIANGULAR KNIFE, DISPOSABLE #TM-1611Arthropedics, Inc.K873711RETROGRADE KNIFE, DISPOSABLE #TM-1613Arthropedics, Inc.K873712STANDARD KNIFE, DISPOSABLE #TM-1610Arthropedics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.