The following data is part of a premarket notification filed by Invuity, Inc. with the FDA for Eigr Surgical Illumination System.
| Device ID | K113697 |
| 510k Number | K113697 |
| Device Name: | EIGR SURGICAL ILLUMINATION SYSTEM |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | INVUITY, INC. 39 STILLMAN STREET San Franciso, CA 94107 |
| Contact | Theresa Brandner-allen |
| Correspondent | Theresa Brandner-allen INVUITY, INC. 39 STILLMAN STREET San Franciso, CA 94107 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-02-10 |