K223183 is an FDA 510(k) clearance for the Light-Guide Cables. This device is classified as a Illuminator, Fiberoptic, Surgical Field (Class II - Special Controls, product code HBI).
Submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on January 13, 2023, 93 days after receiving the submission on October 12, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K223183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2022 |
| Decision Date | January 13, 2023 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HBI — Illuminator, Fiberoptic, Surgical Field |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |