LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated

Electrosurgical, Cutting & Coagulation & Accessories

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Ligasure Maryland Jaw Sealer/divider One-step Sealing, Nano-coated.

Pre-market Notification Details

Device IDK170869
510k NumberK170869
Device Name:LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Covidien 5920 Longbow Drive Boulder,  CO  80301
ContactCelso Duran
CorrespondentCelso Duran
Covidien 5920 Longbow Drive Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-23
Decision Date2017-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521705927 K170869 000
20884521705910 K170869 000
20884521705903 K170869 000

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