OLYMPUS KD SERIES SPHINCTEROTOME

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Kd Series Sphincterotome.

Pre-market Notification Details

Device IDK955247
510k NumberK955247
Device Name:OLYMPUS KD SERIES SPHINCTEROTOME
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactSubhash Patel
CorrespondentSubhash Patel
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-15
Decision Date1996-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170382717 K955247 000
14953170038102 K955247 000
14953170038157 K955247 000
14953170038201 K955247 000
14953170038256 K955247 000
14953170038300 K955247 000
14953170038355 K955247 000
14953170038409 K955247 000
14953170038454 K955247 000
14953170038706 K955247 000
14953170038751 K955247 000
14953170038850 K955247 000
04953170039379 K955247 000
14953170244121 K955247 000
14953170244145 K955247 000
14953170382700 K955247 000
14953170038058 K955247 000

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