KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR

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 Ksea Sawahle Electromechanical Morcellator.

Pre-market Notification Details

Device IDK010346
510k NumberK010346
Device Name:KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentLeigh Spotten
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 Received2001-02-05
Decision Date2001-05-02

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