FDA 510(k)

Resection Electrodes with HF cable

N.º K: K210651 · 2021-08-03

Fecha de decisión2021-08-03

Código de productoFAS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Resection Electrodes with HF cable 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 2021-08-03 under 510(k) number K210651. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Resection Electrodes with HF cable?

Resection Electrodes with HF cable is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K210651.

When did Resection Electrodes with HF cable receive FDA 510(k) clearance?

Resection Electrodes with HF cable received FDA 510(k) clearance on 2021-08-03, under 510(k) number K210651.

Who is the listed applicant for Resection Electrodes with HF cable?

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 Resection Electrodes with HF cable?

The FDA product code for Resection Electrodes with HF cable is FAS.

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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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