PneumoLiner
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Advanced Surgical Concepts
The following data is part of a premarket notification filed by Advanced Surgical Concepts with the FDA for Pneumoliner.
Pre-market Notification Details
| Device ID | K192898 |
| 510k Number | K192898 |
| Device Name: | PneumoLiner |
| Classification | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
| Applicant | Advanced Surgical Concepts Unit 4, Sunnybank Center, Upper Dargle Road Bray, IE A98 E339 |
| Contact | Edward Hyland |
| Product Code | PMU |
| CFR Regulation Number | 884.4050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-11 |
| Decision Date | 2020-02-25 |
| Summary: | summary |
Trademark Results [PneumoLiner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PNEUMOLINER 86646099 5069576 Live/Registered |
Advance Surgical Concepts Limited 2015-05-29 |
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