DeviceClearance

Product code PZQ— General, Plastic Surgery

ContainOR

Classification name
General Laparoscopic Power Morcellation Containment System
Device class
Class 2
Regulation
21 CFR 878.4825
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.”

— U.S. Food and Drug Administration, device classification record for product code PZQ under 21 CFR 878.4825, via openFDA

Market context for product code PZQ

FDA has cleared 1 device under product code PZQ, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PZQ

Recent clearances under product code PZQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.