FDA 510(k)

KARL STORZ UDEL Sterilization Trays

Número K: K201945 · 2021-02-25

RequerenteKarl Storz Endoscopy America, Inc.

Data da decisão2021-02-25

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

KARL STORZ UDEL Sterilization Trays 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 2021-02-25 under 510(k) number K201945. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KARL STORZ UDEL Sterilization Trays?

KARL STORZ UDEL Sterilization Trays is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K201945.

When did KARL STORZ UDEL Sterilization Trays receive FDA 510(k) clearance?

KARL STORZ UDEL Sterilization Trays received FDA 510(k) clearance on 2021-02-25, under 510(k) number K201945.

Who is the listed applicant for KARL STORZ UDEL Sterilization Trays?

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 KARL STORZ UDEL Sterilization Trays?

The FDA product code for KARL STORZ UDEL Sterilization Trays is KCT.

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Outros registros que listam Karl Storz Endoscopy America, Inc. como candidato(a)

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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Fonte oficial

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