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FDA 510(k)

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

Número K: K150969 · 2016-01-08

RequerenteKarl Storz Endoscopy America, Inc.
Data da decisão2016-01-08
Código do produtoERL
Comité consultivoEN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K150969. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces?

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K150969.

When did Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces receive FDA 510(k) clearance?

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces received FDA 510(k) clearance on 2016-01-08, under 510(k) number K150969.

Who is the listed applicant for Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces?

The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces?

The FDA product code for Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces is ERL.

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Dispositivos Relacionados (Código: ERL)

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Fonte oficial

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