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FDA 510(k)

MICROAIRE SMARTDRIVE SYSTEM

K-Number: K955591 · 1996-01-18

ApplicantMicroaire Surgical Instruments, Inc.
Decision Date1996-01-18
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROAIRE SMARTDRIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1996-01-18 under 510(k) number K955591. 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 MICROAIRE SMARTDRIVE SYSTEM?

MICROAIRE SMARTDRIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-18. The listed applicant is Microaire Surgical Instruments, Inc.. The 510(k) number is K955591.

When did MICROAIRE SMARTDRIVE SYSTEM receive FDA 510(k) clearance?

MICROAIRE SMARTDRIVE SYSTEM received FDA 510(k) clearance on 1996-01-18, under 510(k) number K955591.

Who is the listed applicant for MICROAIRE SMARTDRIVE SYSTEM?

The FDA 510(k) record lists Microaire Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROAIRE SMARTDRIVE SYSTEM?

The FDA product code for MICROAIRE SMARTDRIVE SYSTEM is HWE.

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Other records listing Microaire Surgical Instruments, 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.

K014060MICROAIRE 1000E SYSTEMK981922LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRIK973268MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM

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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