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FDA 510(k)

SURGICAL BUR

K-Number: K950449 · 1995-03-01

ApplicantTransidyne General Corp.
Decision Date1995-03-01
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 Transidyne General Corp.. It received FDA 510(k) clearance on 1995-03-01 under 510(k) number K950449. 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 1995-03-01. The listed applicant is Transidyne General Corp.. The 510(k) number is K950449.

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

SURGICAL BUR received FDA 510(k) clearance on 1995-03-01, under 510(k) number K950449.

Who is the listed applicant for SURGICAL BUR?

The FDA 510(k) record lists Transidyne General Corp. 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

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Other records listing Transidyne General Corp. 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.

K961217BODILY FLUID DISPOSAL KITK955658LACERATION TRAYK950773PROPHYLAXIS PACKK950743ORAL PROCEDURE PACKK950403SURGICAL SAW BLADESK924811I.V. START KIT

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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.K943758SURGICAL BURKomet MedicalK934583BURRSAmerican 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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