PZQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- General Laparoscopic Power Morcellation Containment System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4825
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.
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| Record | Firm | Date |
|---|---|---|
| ContainOR (DEN170075) | Advanced Surgical Concepts, Ltd. | 2017-12-19 |
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