The following data is part of a premarket notification filed by Gi Supply, Inc. with the FDA for Everlift Submucosal Lifting Agent.
| Device ID | K202376 |
| 510k Number | K202376 |
| Device Name: | EverLift Submucosal Lifting Agent |
| Classification | Submucosal Injection Agent |
| Applicant | Gi Supply, Inc. 5069 Ritter Road Suite 104 Mechanicsburg, PA 17055 |
| Contact | Erika Parry |
| Correspondent | Erika Parry Gi Supply, Inc. 5069 Ritter Road Suite 104 Mechanicsburg, PA 17055 |
| Product Code | PLL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-20 |
| Decision Date | 2020-09-30 |