Flex-THOR Scope

Laparoscope, General & Plastic Surgery

KARL STORZ Endoscopy-America, Inc.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Flex-thor Scope.

Pre-market Notification Details

Device IDK183264
510k NumberK183264
Device Name:Flex-THOR Scope
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue Ei Segundo,  CA  90245
ContactNozomi Yagi
CorrespondentNozomi Yagi
KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue Ei Segundo,  CA  90245
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-23
Decision Date2019-01-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.