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FDA 510(k)

MICRO-SURGICAL POWER INSTRUMENT SYS.

K-Number: K821487 · 1982-07-02

ApplicantSpire Medical, Inc.
Decision Date1982-07-02
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-SURGICAL POWER INSTRUMENT SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Spire Medical, Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821487. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-SURGICAL POWER INSTRUMENT SYS.?

MICRO-SURGICAL POWER INSTRUMENT SYS. is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Spire Medical, Inc.. The 510(k) number is K821487.

When did MICRO-SURGICAL POWER INSTRUMENT SYS. receive FDA 510(k) clearance?

MICRO-SURGICAL POWER INSTRUMENT SYS. received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821487.

Who is the listed applicant for MICRO-SURGICAL POWER INSTRUMENT SYS.?

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

What is the FDA product code for MICRO-SURGICAL POWER INSTRUMENT SYS.?

The FDA product code for MICRO-SURGICAL POWER INSTRUMENT SYS. is GFA.

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 Spire Medical, 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.

K821485DERMABRADERSK821486MICRO DRILLSK802463MICRO-SURGICAL POWER INSTRUMENT SYSTEMK802503MICRO-SUGICAL POWER INSTRUMENT SYSTEM

Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.K950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven Medical

Official Source

View on FDA Database →

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

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