510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PZQClass II

General Laparoscopic Power Morcellation Containment System

21 CFR 878.4825 / General, Plastic Surgery
FDA source (opens on fda.gov)

PZQ is the FDA product code for General Laparoscopic Power Morcellation Containment System, a class II device type, regulated under 21 CFR 878.4825. FDA's definition for this code reads: "Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PZQ
Device name
General Laparoscopic Power Morcellation Containment System
FDA definition
Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.
Regulation
21 CFR 878.4825
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PZQ

By decision year
1 clearance under product code PZQ with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PZQ by decision year
YearClearances
20171

Applicants with the most clearances

Product code PZQ
Applicants holding the most 510(k) clearances under product code PZQ
ApplicantClearances
Advanced Surgical Concepts1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PZQ.