FDA product code PMU: Containment System, Laparoscopic Power Morcellation, With Instrument Port
PMU is the FDA product code for containment system, laparoscopic power morcellation, with instrument port. It is a Class II device, regulated under 21 CFR 884.4050 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 3 510(k) submissions under PMU, 1 in the last five years, from 3 different applicants. The average 510(k) review took 99 days (median 81); 81 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for PMU devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
| Device class | Class II |
| Regulation | 21 CFR 884.4050 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PMU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 137 |
| 2021 | 1 | 79 |
| 2025 | 1 | 81 |
Compare with all 510(k) review times · Search every PMU clearance
Top PMU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ark Surgical | 1 | 2025-04-15 |
| Agency For Medical Innovations GmbH | 1 | 2021-11-10 |
| Advanced Surgical Concepts | 1 | 2020-02-25 |
Most recent PMU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250212 | Ark Surgical | LapBox Power Tissue Containment System | 2025-04-15 | 81 |
| K212659 | Agency For Medical Innovations GmbH | More-Cell-System | 2021-11-10 | 79 |
| K192898 | Advanced Surgical Concepts | PneumoLiner | 2020-02-25 | 137 |
Recalls for PMU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-09-21.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code PMU?
PMU is the FDA product code for containment system, laparoscopic power morcellation, with instrument port. It is a Class II device, regulated under 21 CFR 884.4050 and reviewed by the Obstetrics and Gynecology panel.
What device class is PMU?
Class II, regulation 21 CFR 884.4050. Typical premarket route: 510(k).
How long does a 510(k) take for product code PMU?
Across 3 cleared submissions the average was 99 days from receipt to decision (median 81).
Which companies have the most PMU clearances?
Ark Surgical (1); Agency For Medical Innovations GmbH (1); Advanced Surgical Concepts (1).
Have PMU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-09-21.
Next steps
- Run an FDA pathway report with predicate devices for product code PMU
- Run a recall and safety report across every PMU manufacturer
- Watch product code PMU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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