The following data is part of a premarket notification filed by Apollo Endosurgery, Inc. with the FDA for Overstitch Endoscopic Suture System.
| Device ID | K081853 |
| 510k Number | K081853 |
| Device Name: | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM |
| Classification | Endoscopic Tissue Approximation Device |
| 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 | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811955020688 | K081853 | 000 |
| 10811955020671 | K081853 | 000 |
| 10811955020664 | K081853 | 000 |