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FDA 510(k)

MICRO DRILLS

K-Number: K821486 · 1982-06-09

ApplicantSpire Medical, Inc.
Decision Date1982-06-09
Product CodeGFG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO DRILLS 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 1982-06-09 under 510(k) number K821486. The device is classified under product code GFG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO DRILLS?

MICRO DRILLS is a medical device that received FDA 510(k) clearance on 1982-06-09. The listed applicant is Spire Medical, Inc.. The 510(k) number is K821486.

When did MICRO DRILLS receive FDA 510(k) clearance?

MICRO DRILLS received FDA 510(k) clearance on 1982-06-09, under 510(k) number K821486.

Who is the listed applicant for MICRO DRILLS?

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 DRILLS?

The FDA product code for MICRO DRILLS is GFG.

Related Clinical Trials

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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.K821485DERMABRADERSK802463MICRO-SURGICAL POWER INSTRUMENT SYSTEMK802503MICRO-SUGICAL POWER INSTRUMENT SYSTEM

Related Devices (Code: GFG)

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.

K935225MITEK MODULAR DRILL BITMitek Surgical Products, Inc.K821127KEY DRILLKey Medical, Inc.

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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