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FDA 510(k)

BURRS

K-Number: K934583 · 1994-01-26

ApplicantAmerican Medical Specialties, Inc.
Decision Date1994-01-26
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BURRS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Specialties, Inc.. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K934583. 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 BURRS?

BURRS is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is American Medical Specialties, Inc.. The 510(k) number is K934583.

When did BURRS receive FDA 510(k) clearance?

BURRS received FDA 510(k) clearance on 1994-01-26, under 510(k) number K934583.

Who is the listed applicant for BURRS?

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

What is the FDA product code for BURRS?

The FDA product code for BURRS 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 American Medical Specialties, 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.

K960482K-WIREK960483STEINMAN PINK934603SURGICAL SAW BLADES

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 MedicalK894438MICRO-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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