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FDA 510(k)

REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS

K-Number: K012676 · 2002-02-04

ApplicantAdven Medical
Decision Date2002-02-04
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS is the device name listed in this FDA 510(k) record. The listed applicant is Adven Medical. It received FDA 510(k) clearance on 2002-02-04 under 510(k) number K012676. 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 REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS?

REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS is a medical device that received FDA 510(k) clearance on 2002-02-04. The listed applicant is Adven Medical. The 510(k) number is K012676.

When did REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS receive FDA 510(k) clearance?

REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS received FDA 510(k) clearance on 2002-02-04, under 510(k) number K012676.

Who is the listed applicant for REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS?

The FDA 510(k) record lists Adven Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS?

The FDA product code for REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS is HWE.

Related Clinical Trials

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.

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Other records listing Adven Medical 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.

K021528REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAPK013987REPROCESSED DISPOSABLE TROCARSK012675REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPSK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSK940501RE-SHARPENABLE SAW BLADES

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

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

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