Device Classification Name |
Containment System, Laparoscopic Power Morcellation, With Instrument Port
|
510(k) Number |
K192898 |
Device Name |
PneumoLiner |
Applicant |
Advanced Surgical Concepts |
Unit 4, Sunnybank Center, Upper Dargle Road |
Bray,
IE
A98 E339
|
|
Applicant Contact |
Edward Hyland |
Correspondent |
Hogan Lovells US LLP |
Columbia Square, 555 Thirteenth Street, NW |
Washington,
DC
20004
|
|
Correspondent Contact |
Jonathan Kahan |
Regulation Number | 884.4050 |
Classification Product Code |
|
Date Received | 10/11/2019 |
Decision Date | 02/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|