The following data is part of a premarket notification filed by Apollo Endosurgery, Inc. with the FDA for Gastric Port, Models: Gap-0016-00, Gap-0018-00, Gap-0020-00.
| Device ID | K082102 |
| 510k Number | K082102 |
| Device Name: | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Contact | Dennis Mcwilliams |
| Correspondent | Dennis Mcwilliams APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-25 |
| Decision Date | 2010-06-14 |
| Summary: | summary |