IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER

Staple, Implantable

COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H

The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for Idrive Ultra Powered Handle And Endo Gia Adapter.

Pre-market Notification Details

Device IDK123318
510k NumberK123318
Device Name:IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
ClassificationStaple, Implantable
Applicant COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven,  CT  06473
ContactSarah Rizk
CorrespondentSarah Rizk
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-25
Decision Date2012-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521144408 K123318 000

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