MODEL 26021C BIPOLAR COAGULATOR

Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

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 Model 26021c Bipolar Coagulator.

Pre-market Notification Details

Device IDK871745
510k NumberK871745
Device Name:MODEL 26021C BIPOLAR COAGULATOR
ClassificationCoagulator-cutter, Endoscopic, Bipolar (and Accessories)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
ContactNorman Silbertrust
CorrespondentNorman Silbertrust
KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
Product CodeHIN  
CFR Regulation Number884.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-05
Decision Date1987-07-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.