KSEA STEINER ELECTROMECHANIC 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 Steiner Electromechanic Morcellator.

Pre-market Notification Details

Device IDK950339
510k NumberK950339
Device Name:KSEA STEINER ELECTROMECHANIC MORCELLATOR
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactMarika Anderson
CorrespondentMarika Anderson
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 Received1995-01-27
Decision Date1995-04-06

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