KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION

Resectoscope

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 Cutting Loop Electrodes Modification.

Pre-market Notification Details

Device IDK934647
510k NumberK934647
Device Name:KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
ClassificationResectoscope
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
ContactRobert R Giorgini
CorrespondentRobert R Giorgini
KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
Product CodeFJL  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-29
Decision Date1994-02-09

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