Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K230801 |
Device Name |
Pathfinder Endoscope Overtube with Balloon Device |
Applicant |
Neptune Medical, Inc. |
1828 El Camino Real, Suite 508 |
Burlingame,
CA
94010
|
|
Applicant Contact |
Alex Tilson |
Correspondent |
Alvamed, Inc. |
935 Great Plain Ave, Suite 166 |
Needham,
MA
02492
|
|
Correspondent Contact |
Eric Bannon |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/23/2023 |
Decision Date | 07/28/2023 |
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
|
|
|