FDA 510(k)

HOPKINS Telescopes

N.º K: K221004 · 2022-12-20

SolicitanteKarl Storz Endoscopy America, Inc.

Fecha de decisión2022-12-20

Código de productoGCJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

HOPKINS Telescopes 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 2022-12-20 under 510(k) number K221004. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HOPKINS Telescopes?

HOPKINS Telescopes is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K221004.

When did HOPKINS Telescopes receive FDA 510(k) clearance?

HOPKINS Telescopes received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221004.

Who is the listed applicant for HOPKINS Telescopes?

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 HOPKINS Telescopes?

The FDA product code for HOPKINS Telescopes is GCJ.

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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

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