FDA 510(k)

Instrument basket, for EndoEYE

N.º K: K171692 · 2018-04-02

Fecha de decisión2018-04-02

Código de productoKCT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Instrument basket, for EndoEYE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2018-04-02 under 510(k) number K171692. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Instrument basket, for EndoEYE?

Instrument basket, for EndoEYE is a medical device that received FDA 510(k) clearance on 2018-04-02. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K171692.

When did Instrument basket, for EndoEYE receive FDA 510(k) clearance?

Instrument basket, for EndoEYE received FDA 510(k) clearance on 2018-04-02, under 510(k) number K171692.

Who is the listed applicant for Instrument basket, for EndoEYE?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Instrument basket, for EndoEYE?

The FDA product code for Instrument basket, for EndoEYE is KCT.

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Otros registros que enlistan a Olympus Winter & Ibe GmbH como solicitante

K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)K221522HF-cables (resusable)K223183Light-Guide Cables K213207Sheath, Stopcock Accessory

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Fuente oficial

Ver en la base de datos de la FDA →

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