KARL STORZ ENDOSCOPIC COLD KNIFE BLADES

Urethrotome

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 Endoscopic Cold Knife Blades.

Pre-market Notification Details

Device IDK934730
510k NumberK934730
Device Name:KARL STORZ ENDOSCOPIC COLD KNIFE BLADES
ClassificationUrethrotome
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactRobert R Giorgini
CorrespondentRobert R Giorgini
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeEZO  
CFR Regulation Number876.4770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-01
Decision Date1994-01-11

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