FDA 510(k)

HOPKINS Telescopes

Número K: K223885 · 2023-09-14

RequerenteKarl Storz Endoscopy America, Inc.

Data da decisão2023-09-14

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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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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Fonte oficial

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