The following data is part of a premarket notification filed by Apollo Endosurgery Inc with the FDA for Overstitch Sx Endoscopic Suturing System (ess).
| Device ID | K171886 |
| 510k Number | K171886 |
| Device Name: | OverStitch SX Endoscopic Suturing System (ESS) |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | Apollo Endosurgery Inc 1120 S. Capital Of Texas Hwy. Ste 300 Austin, TX 78746 |
| Contact | Maritza Ward |
| Correspondent | Maritza Ward Apollo Endosurgery Inc 1120 S. Capital Of Texas Hwy. Ste 300 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 | 2017-06-26 |
| Decision Date | 2017-11-15 |
| Summary: | summary |