The following data is part of a premarket notification filed by Gi Supply with the FDA for Everlift Submucosal Lifting Agent.
| Device ID | K191923 |
| 510k Number | K191923 |
| Device Name: | EverLift Submucosal Lifting Agent |
| Classification | Submucosal Injection Agent |
| Applicant | GI Supply 5069 Ritter Road, Suite 104 Mechanicsburg, PA 17055 |
| Contact | Erika Parry |
| Correspondent | Erika Parry GI Supply 5069 Ritter Road, Suite 104 Mechanicsburg, PA 17055 |
| Product Code | PLL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-18 |
| Decision Date | 2020-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893029002229 | K191923 | 000 |