FDA 510(k)

Telepack +

N.º K: K221174 · 2022-05-13

SolicitanteKarl Storz Endoscopy America, Inc.

Fecha de decisión2022-05-13

Código de productoFET

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Telepack + 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 2022-05-13 under 510(k) number K221174. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Telepack +?

Telepack + is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K221174.

When did Telepack + receive FDA 510(k) clearance?

Telepack + received FDA 510(k) clearance on 2022-05-13, under 510(k) number K221174.

Who is the listed applicant for Telepack +?

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 Telepack +?

The FDA product code for Telepack + is FET.

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Otros registros que enlistan a Karl Storz Endoscopy America, Inc. como solicitante

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes

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Fuente oficial

Ver en la base de datos de la FDA →

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