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FDA 510(k)

KOMET SURGICAL BUR

K-Number: K883255 · 1988-09-15

ApplicantKomet Medical, Div. of Brasseler USA I, L.P.
Decision Date1988-09-15
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KOMET SURGICAL BUR is the device name listed in this FDA 510(k) record. The listed applicant is Komet Medical, Div. of Brasseler USA I, L.P.. It received FDA 510(k) clearance on 1988-09-15 under 510(k) number K883255. 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 KOMET SURGICAL BUR?

KOMET SURGICAL BUR is a medical device that received FDA 510(k) clearance on 1988-09-15. The listed applicant is Komet Medical, Div. of Brasseler USA I, L.P.. The 510(k) number is K883255.

When did KOMET SURGICAL BUR receive FDA 510(k) clearance?

KOMET SURGICAL BUR received FDA 510(k) clearance on 1988-09-15, under 510(k) number K883255.

Who is the listed applicant for KOMET SURGICAL BUR?

The FDA 510(k) record lists Komet Medical, Div. of Brasseler USA I, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOMET SURGICAL BUR?

The FDA product code for KOMET SURGICAL BUR is GFF.

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

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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