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FDA 510(k)

DERMABRADERS

K-Number: K821485 · 1982-06-10

ApplicantSpire Medical, Inc.
Decision Date1982-06-10
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMABRADERS 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 1982-06-10 under 510(k) number K821485. The device is classified under product code GFF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMABRADERS?

DERMABRADERS is a medical device that received FDA 510(k) clearance on 1982-06-10. The listed applicant is Spire Medical, Inc.. The 510(k) number is K821485.

When did DERMABRADERS receive FDA 510(k) clearance?

DERMABRADERS received FDA 510(k) clearance on 1982-06-10, under 510(k) number K821485.

Who is the listed applicant for DERMABRADERS?

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 DERMABRADERS?

The FDA product code for DERMABRADERS is GFF.

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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.K821486MICRO DRILLSK802463MICRO-SURGICAL POWER INSTRUMENT SYSTEMK802503MICRO-SUGICAL POWER INSTRUMENT SYSTEM

Related Devices (Code: GFF)

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.

K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.K950449SURGICAL BURTransidyne General Corp.K943758SURGICAL BURKomet MedicalK934583BURRSAmerican Medical Specialties, Inc.K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.K890090DANEK IRRIGATING BURR (DIB) SETDanek Medical, Inc.

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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