KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS

Forceps, Biopsy, Electric

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 Insulated Biopsy Forceps, Grasping/dissecting Forecps, Flexible Forceps.

Pre-market Notification Details

Device IDK944765
510k NumberK944765
Device Name:KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
ClassificationForceps, Biopsy, Electric
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactBetty M Johnson
CorrespondentBetty M Johnson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeKGE  
Subsequent Product CodeFDI
Subsequent Product CodeGDI
Subsequent Product CodeKNS
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-27
Decision Date1995-03-28

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