The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Endius Spine Endoscope.
| Device ID | K982819 |
| 510k Number | K982819 |
| Device Name: | ENDIUS SPINE ENDOSCOPE |
| Classification | Endoscope, Neurological |
| Applicant | ENDIUS, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress ENDIUS, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-11 |
| Decision Date | 1999-01-27 |