FDA 510(k)

HOPKINS Telescopes

N.º K: K223885 · 2023-09-14

SolicitanteKarl Storz Endoscopy America, Inc.

Fecha de decisión2023-09-14

Código de productoHIH

Comité asesorOB

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 2023-09-14 under 510(k) number K223885. The device is classified under product code HIH. It was reviewed by the OB 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 2023-09-14. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K223885.

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

HOPKINS Telescopes received FDA 510(k) clearance on 2023-09-14, under 510(k) number K223885.

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 HIH.

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

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders 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 K221893KARL STORZ Bipolar Resectoscopes with HF Cable

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.