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FDA 510(k)

GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER

K-Number: K942574 · 1994-09-28

ApplicantAcufex Microsurgical, Inc.
Decision Date1994-09-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER 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 K942574. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER?

GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER 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 K942574.

When did GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER receive FDA 510(k) clearance?

GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER received FDA 510(k) clearance on 1994-09-28, under 510(k) number K942574.

Who is the listed applicant for GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER?

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 GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER?

The FDA product code for GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER is GCJ.

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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 TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

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Related Devices (Code: GCJ)

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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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