Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable

Electrosurgical, Cutting & Coagulation & Accessories

Integra LifeSciences Corporation

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable.

Pre-market Notification Details

Device IDK182801
510k NumberK182801
Device Name:Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield,  MA  02048
ContactJennifer Siu
CorrespondentJennifer Siu
Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield,  MA  02048
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-02
Decision Date2018-11-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704081760 K182801 000
10886704081722 K182801 000
10886704081692 K182801 000
10381780532873 K182801 000

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