DEN170075 is an FDA 510(k) submission for the ContainOR. This device is classified as a General Laparoscopic Power Morcellation Containment System (Class II - Special Controls, product code PZQ).
Submitted by Advanced Surgical Concepts, Ltd. (Bray, IE). The FDA issued a Not Cleared (DENG) decision on December 19, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4825. Intended For Use As A Bag Containment System By Qualified Surgeons For Tissue Extraction And/or Power Morcellation During General Laparoscopic Procedures..
| 510(k) Number | DEN170075 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 29, 2017 |
| Decision Date | December 19, 2017 |
| Days to Decision | 81 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | PZQ - General Laparoscopic Power Morcellation Containment System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4825 |
| Definition | Intended For Use As A Bag Containment System By Qualified Surgeons For Tissue Extraction And/or Power Morcellation During General Laparoscopic Procedures. |