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FDA 510(k)

ACUFEX STERILE DRILLS

K-Number: K931837 · 1994-01-07

ApplicantAcufex Microsurgical, Inc.
Decision Date1994-01-07
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUFEX STERILE DRILLS 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 1994-01-07 under 510(k) number K931837. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX STERILE DRILLS?

ACUFEX STERILE DRILLS is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K931837.

When did ACUFEX STERILE DRILLS receive FDA 510(k) clearance?

ACUFEX STERILE DRILLS received FDA 510(k) clearance on 1994-01-07, under 510(k) number K931837.

Who is the listed applicant for ACUFEX STERILE DRILLS?

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 STERILE DRILLS?

The FDA product code for ACUFEX STERILE DRILLS is HWE.

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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: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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