GYRUS ACMI BICOAG HEMOSTASIS PROBE

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

OLYMPUS SURGICAL TECHNOLOGIES AMERICA

The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Gyrus Acmi Bicoag Hemostasis Probe.

Pre-market Notification Details

Device IDK123319
510k NumberK123319
Device Name:GYRUS ACMI BICOAG HEMOSTASIS PROBE
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough,  MA  01772
ContactNeil Kelly
CorrespondentNeil Kelly
OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough,  MA  01772
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-26
Decision Date2012-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925039483 K123319 000
00821925039476 K123319 000
00821925039469 K123319 000
00821925039452 K123319 000

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