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FDA 510(k)

MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO

K-Number: K912205 · 1991-08-16

ApplicantMicroaire
Decision Date1991-08-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO is the device name listed in this FDA 510(k) record. The listed applicant is Microaire. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K912205. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO?

MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Microaire. The 510(k) number is K912205.

When did MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO receive FDA 510(k) clearance?

MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO received FDA 510(k) clearance on 1991-08-16, under 510(k) number K912205.

Who is the listed applicant for MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO?

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

What is the FDA product code for MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO?

The FDA product code for MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO is HRX.

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 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.

K915670MICROAIRE MODEL 2600K912206MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO.

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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