The following data is part of a premarket notification filed by Apollo Endosurgery, Inc. with the FDA for Overtube Endoscopic Access System.
| Device ID | K122270 |
| 510k Number | K122270 |
| Device Name: | OVERTUBE ENDOSCOPIC ACCESS SYSTEM |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Contact | Heather Crawford, Rac |
| Correspondent | Heather Crawford, Rac APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-09-28 |
| Summary: | summary |