OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)

Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Pr-23q Disposable Cannula (ball Tip).

Pre-market Notification Details

Device IDK950729
510k NumberK950729
Device Name:OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
ClassificationEndoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Applicant OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
ContactBarry Sands
CorrespondentBarry Sands
OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
Product CodeODD  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-16
Decision Date1995-03-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170225007 K950729 000
14953170154680 K950729 000
14953170154659 K950729 000
14953170154635 K950729 000
14953170154604 K950729 000
14953170154574 K950729 000
14953170043885 K950729 000
14953170043847 K950729 000
14953170043762 K950729 000
14953170043724 K950729 000
14953170043601 K950729 000
14953170043571 K950729 000
14953170043175 K950729 000
14953170043168 K950729 000
04953170043130 K950729 000
14953170154697 K950729 000
14953170154703 K950729 000
14953170154710 K950729 000
14953170183833 K950729 000
14953170183819 K950729 000
14953170183796 K950729 000
14953170183772 K950729 000
14953170183758 K950729 000
14953170183734 K950729 000
14953170183710 K950729 000
14953170183697 K950729 000
14953170183635 K950729 000
14953170183611 K950729 000
14953170183574 K950729 000
14953170183550 K950729 000
14953170154734 K950729 000
14953170154727 K950729 000
14953170043113 K950729 000

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