The following data is part of a premarket notification filed by Apollo Endosurgery with the FDA for Overstitch Endoscopic Suturing System And Accessories.
| Device ID | K181141 |
| 510k Number | K181141 |
| Device Name: | OverStitch Endoscopic Suturing System And Accessories |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | Apollo Endosurgery 1120 S. Capital Of Texas Hwy Ste. 300 Austin, TX 78746 |
| Contact | Maritza Ward |
| Correspondent | Maritza Ward Apollo Endosurgery 1120 S. Capital Of Texas Hwy Ste. 300 Austin, TX 78746 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-06-27 |
| Summary: | summary |