SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Single Use Electrosurgical Knife Series, Model Kd-610l, Kd-611l, Kd-620lr, Kd-630l, Kf-640l.

Pre-market Notification Details

Device IDK092309
510k NumberK092309
Device Name:SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034
ContactStacy Abbatiello Kluesner
CorrespondentStacy Abbatiello Kluesner
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-30
Decision Date2009-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170325936 K092309 000
14953170462334 K092309 000
14953170453998 K092309 000
14953170453981 K092309 000
14953170453974 K092309 000
14953170453967 K092309 000
14953170453950 K092309 000
14953170453943 K092309 000
14953170453936 K092309 000
14953170208406 K092309 000
14953170208413 K092309 000
14953170208420 K092309 000
14953170325899 K092309 000
14953170265782 K092309 000
14953170265775 K092309 000
14953170265768 K092309 000
14953170251518 K092309 000
14953170251501 K092309 000
14953170225960 K092309 000
14953170208543 K092309 000
14953170453929 K092309 000

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