K111342 is an FDA 510(k) clearance for the LIGHT GUIDE CABLE, a Illuminator, Fiberoptic, Surgical Field (Class II — Special Controls, product code HBI), submitted by Schott North America (North Attleboro, US). The FDA issued a Cleared decision on November 25, 2011, 196 days after receiving the submission on May 13, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K111342 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 13, 2011 |
| Decision Date | November 25, 2011 |
| Days to Decision | 196 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 |