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

Containment System, Laparoscopic Power Morcellation, With Instrument Port

21 CFR 884.4050 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PMU is the FDA product code for Containment System, Laparoscopic Power Morcellation, With Instrument Port, a class II device type, regulated under 21 CFR 884.4050. FDA's definition for this code reads: "Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PMU
Device name
Containment System, Laparoscopic Power Morcellation, With Instrument Port
FDA definition
Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
Regulation
21 CFR 884.4050
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code PMU

By decision year
4 clearances under product code PMU with a decision year between 2016 and 2025, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PMU by decision year
YearClearances
20161
20201
20211
20251

Applicants with the most clearances

Product code PMU
Applicants holding the most 510(k) clearances under product code PMU
ApplicantClearances
Advanced Surgical Concepts2
Agency for Medical Innovations Inc.1
Ark Surgical1

Companies listing this code with FDA

Companies whose registered establishments list this code