DEN150028 is an FDA 510(k) submission for the PneumoLiner. This device is classified as a Containment System, Laparoscopic Power Morcellation, With Instrument Port (Class II - Special Controls, product code PMU).
Submitted by Advanced Surgical Concepts, Ltd. (Bray, IE). The FDA issued a Not Cleared (DENG) decision on April 7, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4050. 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..
| 510(k) Number | DEN150028 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 19, 2015 |
| Decision Date | April 07, 2016 |
| Days to Decision | 293 days |
| Submission Type | Direct |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | PMU - Containment System, Laparoscopic Power Morcellation, With Instrument Port |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4050 |
| 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. |