The following data is part of a De Novo classification by Advanced Surgical Concepts Ltd. with the FDA for Containor.
| DeNovo ID | DEN170075 |
| Device Name: | ContainOR |
| Classification | General Laparoscopic Power Morcellation Containment System |
| Applicant | Advanced Surgical Concepts Ltd. unit 4 Sunnybank Center, Upper Dargle Road Bray, IE A98 E339 |
| Contact | Edward Hyland |
| Product Code | PZQ |
| CFR Regulation Number | 878.4825 [🔎] |
| 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 | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2017-09-29 |
| Decision Date | 2017-12-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |