Device Classification Name |
endoscopic tissue approximation device
|
510(k) Number |
K210266 |
Device Name |
OverStitch Sx Endoscopic Suturing System |
Applicant |
Apollo Endosurgery Inc. |
1120 South Capital of Texas Hwy., Suite 300 |
Austin,
TX
78746
|
|
Applicant Contact |
David Hooper |
Correspondent |
Apollo Endosurgery Inc. |
1120 South Capital of Texas Hwy., Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
David Hooper |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/01/2021 |
Decision Date | 03/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|