The following data is part of a premarket notification filed by Apollo Endosurgery with the FDA for Overstitch 2-0 Polypropylene Suture.
| Device ID | K191439 |
| 510k Number | K191439 |
| Device Name: | OverStitch 2-0 Polypropylene Suture |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | Apollo Endosurgery 1120 S. Capital Of Texas Hwy Austin, TX 78746 |
| Contact | Maritza Ward |
| Correspondent | David M Hooper Apollo Endosurgery 1120 S. Capital Of Texas Hwy 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 | 2019-05-30 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811955020735 | K191439 | 000 |