K113697 is an FDA 510(k) clearance for the EIGR SURGICAL ILLUMINATION SYSTEM. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Invuity, Inc. (San Franciso, US). The FDA issued a Cleared decision on February 10, 2012, 56 days after receiving the submission on December 16, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K113697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2011 |
| Decision Date | February 10, 2012 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FST - Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |