The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Operascope Needle.
| Device ID | K221085 |
| 510k Number | K221085 |
| Device Name: | LiNA OperaScope Needle |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | LiNA Medical ApS Formervangen 5 Glostrup, DK 2600 |
| Contact | Jaroslaw Mrówczynski |
| Correspondent | Scott Blood MEDIcept, Inc. 200 Homer Avenue Ashland, MA 01821 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-13 |
| Decision Date | 2022-09-02 |