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FDA 510(k)

MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM

K-Number: K973268 · 1997-11-26

ApplicantMicroaire Surgical Instruments, Inc.
Decision Date1997-11-26
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROAIRE POWER ASPIRATION DEVICE PAD 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 1997-11-26 under 510(k) number K973268. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM?

MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Microaire Surgical Instruments, Inc.. The 510(k) number is K973268.

When did MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM receive FDA 510(k) clearance?

MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM received FDA 510(k) clearance on 1997-11-26, under 510(k) number K973268.

Who is the listed applicant for MICROAIRE POWER ASPIRATION DEVICE PAD 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 POWER ASPIRATION DEVICE PAD SYSTEM?

The FDA product code for MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM is BTA.

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.

K014060MICROAIRE 1000E SYSTEMK981922LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRIK955591MICROAIRE SMARTDRIVE SYSTEM

Related Devices (Code: BTA)

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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

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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