FDA 510(k), K161112, KARL STORZ Flexible Video-Neuro-Endoscope System
FDA 510(k), K161112, KARL STORZ Flexible Video-Neuro-Endoscope System
510(K) Number: K161112
Device Name: KARL STORZ Flexible Video-Neuro-Endoscope System
Manufacturer: SUSIE S. CHEN
Device Classification Name: Endoscope, Neurological
Regulation Number: GWG
Classification Product Code: KXA
Date Received: 04/20/2016
Decision Date: 09/17/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Total pages: 658
Fully redacted pages: 507
Content pages: 151
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