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FDA 510(k)

MICRO-SUGICAL POWER INSTRUMENT SYSTEM

K-Number: K802503 · 1980-10-31

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

Device Summary

MICRO-SUGICAL 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 K802503. The device is classified under product code EQJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-SUGICAL POWER INSTRUMENT SYSTEM?

MICRO-SUGICAL 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 K802503.

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

MICRO-SUGICAL POWER INSTRUMENT SYSTEM received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802503.

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

The FDA product code for MICRO-SUGICAL POWER INSTRUMENT SYSTEM is EQJ.

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.

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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 DRILLSK802463MICRO-SURGICAL POWER INSTRUMENT SYSTEM

Related Devices (Code: EQJ)

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.

K161514Precision Thin Reciprocating Blade, 0.010in.Stryker CorporationK041985XPS CURVED BURMedtronic Xomed, Inc.K974232ESSENTIAL SHAVER SYSTEMGyrus Ent LLCK960853ACE SYSTEMXomed, Inc.K955704TREBAY MICRODEBRIDER SYSTEMTrebay Medical Corp.K955294SOF - ABRASION BURTrebay Medical Corp.

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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