K200874 is an FDA 510(k) clearance for the TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 30, 2020, 90 days after receiving the submission on April 1, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K200874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2020 |
| Decision Date | June 30, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FST — Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |