CALCULASE II

Powered Laser Surgical Instrument

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 Calculase Ii.

Pre-market Notification Details

Device IDK140964
510k NumberK140964
Device Name:CALCULASE II
ClassificationPowered Laser Surgical Instrument
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245 -5017
ContactWinkie Wong
CorrespondentWinkie Wong
KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245 -5017
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-15
Decision Date2014-09-04
Summary:summary

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