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FDA 510(k)

SURGICAL BUR

K-Number: K943758 · 1994-08-22

ApplicantKomet Medical
Decision Date1994-08-22
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL BUR is the device name listed in this FDA 510(k) record. The listed applicant is Komet Medical. It received FDA 510(k) clearance on 1994-08-22 under 510(k) number K943758. 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 SURGICAL BUR?

SURGICAL BUR is a medical device that received FDA 510(k) clearance on 1994-08-22. The listed applicant is Komet Medical. The 510(k) number is K943758.

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

SURGICAL BUR received FDA 510(k) clearance on 1994-08-22, under 510(k) number K943758.

Who is the listed applicant for SURGICAL BUR?

The FDA 510(k) record lists Komet Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL BUR?

The FDA product code for 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

Other records listing Komet Medical 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.

K991625KOMET XK-95 PERFORATOR MOTOR (MI-102)K984035XK-95 HIGH SPEED MOTOR DRILL 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.K934583BURRSAmerican Medical Specialties, Inc.K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.K890090DANEK IRRIGATING BURR (DIB) SETDanek Medical, Inc.K883255KOMET SURGICAL BURKomet Medical, Div. of Brasseler USA I, L.P.

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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