FDA 510(k)

KARL STORZ Flexible Video-Neuro-Endoscope System

Número K: K161112 · 2016-09-17

RequerenteKARL STORZ Endoscopy-America, Inc.

Data da decisão2016-09-17

Código do produtoGWG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

KARL STORZ Flexible Video-Neuro-Endoscope System 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 2016-09-17 under 510(k) number K161112. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KARL STORZ Flexible Video-Neuro-Endoscope System?

KARL STORZ Flexible Video-Neuro-Endoscope System is a medical device that received FDA 510(k) clearance on 2016-09-17. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K161112.

When did KARL STORZ Flexible Video-Neuro-Endoscope System receive FDA 510(k) clearance?

KARL STORZ Flexible Video-Neuro-Endoscope System received FDA 510(k) clearance on 2016-09-17, under 510(k) number K161112.

Who is the listed applicant for KARL STORZ Flexible Video-Neuro-Endoscope System?

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 Flexible Video-Neuro-Endoscope System?

The FDA product code for KARL STORZ Flexible Video-Neuro-Endoscope System is GWG.

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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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