Device Classification Name |
Endoscopic Access Overtube, Gastroenterology-Urology
|
510(k) Number |
K191415 |
Device Name |
Pathfinder Endoscope Overtube |
Applicant |
Neptune Medical, Inc. |
1828 El Camino Real, Suite 508 |
Burlingame,
CA
94010
|
|
Applicant Contact |
Alex Tilson |
Correspondent |
AlvaMed, Inc. |
935 Great Plain Avenue, #166 |
Needham,
MA
02492
|
|
Correspondent Contact |
Ian Broome |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/28/2019 |
Decision Date | 08/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|