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FDA 510(k)

ARTUS DISPOSABLE SHEATHS/CUTTERS

K-Number: K880881 · 1988-05-04

ApplicantAcufex Microsurgical, Inc.
Decision Date1988-05-04
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTUS DISPOSABLE SHEATHS/CUTTERS 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 1988-05-04 under 510(k) number K880881. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTUS DISPOSABLE SHEATHS/CUTTERS?

ARTUS DISPOSABLE SHEATHS/CUTTERS is a medical device that received FDA 510(k) clearance on 1988-05-04. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K880881.

When did ARTUS DISPOSABLE SHEATHS/CUTTERS receive FDA 510(k) clearance?

ARTUS DISPOSABLE SHEATHS/CUTTERS received FDA 510(k) clearance on 1988-05-04, under 510(k) number K880881.

Who is the listed applicant for ARTUS DISPOSABLE SHEATHS/CUTTERS?

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 ARTUS DISPOSABLE SHEATHS/CUTTERS?

The FDA product code for ARTUS DISPOSABLE SHEATHS/CUTTERS is HSZ.

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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: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.

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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