FDA Product Code PMU: Containment System, Laparoscopic Power Morcellation, With Instrument Port
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.
Leading manufacturers include Agency For Medical Innovations GmbH and Ark Surgical.
FDA 510(k) Cleared Containment System, Laparoscopic Power Morcellation, With Instrument Port Devices (Product Code PMU)
About Product Code PMU - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PMU since 2016, with 3 receiving FDA clearance (average review time: 148 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PMU have taken an average of 81 days to reach a decision - down from 170 days historically, suggesting improved FDA processing for this classification.
PMU devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →