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FDA 510(k)

MICROAIRE 1000E SYSTEM

K-Number: K014060 · 2002-03-05

ApplicantMicroaire Surgical Instruments, Inc.
Decision Date2002-03-05
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICROAIRE 1000E 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 2002-03-05 under 510(k) number K014060. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROAIRE 1000E SYSTEM?

MICROAIRE 1000E SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-05. The listed applicant is Microaire Surgical Instruments, Inc.. The 510(k) number is K014060.

When did MICROAIRE 1000E SYSTEM receive FDA 510(k) clearance?

MICROAIRE 1000E SYSTEM received FDA 510(k) clearance on 2002-03-05, under 510(k) number K014060.

Who is the listed applicant for MICROAIRE 1000E 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 1000E SYSTEM?

The FDA product code for MICROAIRE 1000E SYSTEM is HBE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K981922LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRIK973268MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEMK955591MICROAIRE SMARTDRIVE SYSTEM

Related Devices (Code: HBE)

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.

K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)Surgify Medical OYK250815Hubly Drill (H100)Hubly, Inc.K252060GREENPhasor Health, LLCK252662UniBurNakanishi, Inc.K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)Surgify Medical OYK250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)Surgify Medical OY

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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