PZQ — General Laparoscopic Power Morcellation Containment System Class II
FDA product code PZQ covers "General Laparoscopic Power Morcellation Containment System", a Class II medical device regulated under 21 CFR 878.4825. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PZQ
- Device Class
- Class II
- Regulation Number
- 878.4825
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170075 | advanced surgical concepts | ContainOR | December 19, 2017 |