General Laparoscopic Power Morcellation Containment System
The General Laparoscopic Power Morcellation Containment System is a surgical device intended for use by qualified surgeons as a bag containment system during general laparoscopic procedures to facilitate tissue extraction and/or power morcellation while minimizing the risk of tissue dissemination within the abdominal cavity. It is classified as a Class 2 device under regulation 878.4825, requiring 510(k) premarket notification before marketing, and falls within the General, Plastic Surgery (SU) medical specialty. The product code is PZQ. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZQ
- Device Class
- FDA class 2
- Regulation Number
- 878.4825
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN170075 | ContainOR | Dec 19, 2017 | Unknown | Advanced Surgical Concepts, Ltd. |