PneumoLiner

Containment System, Laparoscopic Power Morcellation, With Instrument Port

ADVANCED SURGICAL CONCEPTS LTD.

The following data is part of a De Novo classification by Advanced Surgical Concepts Ltd. with the FDA for Pneumoliner.

Pre-market Notification Details

DeNovo IDDEN150028
Device Name:PneumoLiner
ClassificationContainment System, Laparoscopic Power Morcellation, With Instrument Port
Applicant ADVANCED SURGICAL CONCEPTS LTD. unit 4 Sunnybank Center, Upper Dargle Road Bray,  IE Irl
ContactEdward Hyland
Product CodePMU  
CFR Regulation Number884.4050 [🔎]
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 BoardObstetrics/Gynecology
Classification AdvisoryObstetrics/Gynecology
TypeDirect
Date Received2015-06-19
Decision Date2016-04-07
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391530440011 DEN150028 000

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