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FDA 510(k)

MICRO-SURGICAL POWER INSTRUMENT SYSTEM

K-Number: K802463 · 1980-10-31

ApplicantSpire Medical, Inc.
Decision Date1980-10-31
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICRO-SURGICAL POWER INSTRUMENT SYSTEM 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 1980-10-31 under 510(k) number K802463. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-SURGICAL POWER INSTRUMENT SYSTEM?

MICRO-SURGICAL POWER INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Spire Medical, Inc.. The 510(k) number is K802463.

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

MICRO-SURGICAL POWER INSTRUMENT SYSTEM received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802463.

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

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 SYSTEM?

The FDA product code for MICRO-SURGICAL POWER INSTRUMENT SYSTEM is ERL.

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.

K821487MICRO-SURGICAL POWER INSTRUMENT SYS.K821485DERMABRADERSK821486MICRO DRILLSK802503MICRO-SUGICAL POWER INSTRUMENT SYSTEM

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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