Flexible Intubation Video Endoscope – Sterile (FIVE-S)

Bronchoscope (flexible Or Rigid)

KARL STORZ Endoscopy America

The following data is part of a premarket notification filed by Karl Storz Endoscopy America with the FDA for Flexible Intubation Video Endoscope – Sterile (five-s).

Pre-market Notification Details

Device IDK212656
510k NumberK212656
Device Name:Flexible Intubation Video Endoscope – Sterile (FIVE-S)
ClassificationBronchoscope (flexible Or Rigid)
Applicant KARL STORZ Endoscopy America 2151 E. Grand Avenue El Segundo,  CA  90245
ContactMario Trujillo
CorrespondentMario Trujillo
KARL STORZ Endoscopy America 2151 E. Grand Avenue El Segundo,  CA  90245
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2021-12-29

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