| DeNovo ID | DEN150028 |
| Device Name: | PneumoLiner |
| Classification | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
| Applicant | ADVANCED SURGICAL CONCEPTS LTD. unit 4 Sunnybank Center, Upper Dargle Road Bray, IE Irl |
| Contact | Edward Hyland |
| Product Code | PMU |
| CFR Regulation Number | 884.4050 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device 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 Board | Obstetrics/Gynecology |
| Classification Advisory | Obstetrics/Gynecology |
| Type | Direct |
| Date Received | 2015-06-19 |
| Decision Date | 2016-04-07 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |