The following data is part of a premarket notification filed by Apollo Endosurgery, Inc. with the FDA for X-tack Endoscopic Helix Tacking System.
| Device ID | K201808 |
| 510k Number | K201808 |
| Device Name: | X-Tack Endoscopic HeliX Tacking System |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Apollo Endosurgery, Inc. 1120 S. Capital Of Texas Hwy Austin, TX 78749 |
| Contact | Natalie Allen |
| Correspondent | Natalie Allen Apollo Endosurgery, Inc. 1120 S. Capital Of Texas Hwy Austin, TX 78749 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2020-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20811955020777 | K201808 | 000 |
| 20811955020760 | K201808 | 000 |
| 20811955020753 | K201808 | 000 |