LigaSure Maryland Jaw Thoracic 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 Thoracic Sealer/divider One-step Sealing, Nano-coated.

Pre-market Notification Details

Device IDK181085
510k NumberK181085
Device Name:LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Covidien 5920 Longbow Drive Boulder,  CO  80301
ContactJames R. Davis
CorrespondentJames R. Davis
Covidien 5920 Longbow Drive Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-25
Decision Date2018-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521751047 K181085 000

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