KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC

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 Karl Storz Biop/bask Cut/grasp Dissec/flex/cut Forc.

Pre-market Notification Details

Device IDK934937
510k NumberK934937
Device Name:KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-12
Decision Date1994-03-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551098479 K934937 000
04048551098370 K934937 000
04048551086780 K934937 000

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