KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS

Arthroscope

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 Karl Stortz Obturator)sharp/blunt)/cannulae/sheaths.

Pre-market Notification Details

Device IDK943154
510k NumberK943154
Device Name:KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
ClassificationArthroscope
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactBetty M Johnson
CorrespondentBetty M Johnson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-30
Decision Date1994-12-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551095836 K943154 000
04048551094723 K943154 000

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