Endoscopic Traction Device

Covidien LLC

The following data is part of a De Novo classification by Covidien Llc with the FDA for Prodigi.

Pre-market Notification Details

DeNovo IDDEN220006
Device Name:ProdiGI
ClassificationEndoscopic Traction Device
Applicant Covidien LLC 3062 Bunker Hill Lane Santa Clara,  CA  95054
ContactLiron Bar Yaakov
Product CodeQSW  
CFR Regulation Number876.4410 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
Date Received2022-01-14
Decision Date2022-06-13
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
10884521808386 DEN220006 000
10884521806870 DEN220006 000
10884521806863 DEN220006 000

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