K101496 is an FDA 510(k) clearance for the CABLECAP MODEL: WLF, STZ, ACM, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Sensormed (Knoxville, US). The FDA issued a Cleared decision on September 14, 2010, 105 days after receiving the submission on June 1, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K101496 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2010 |
| Decision Date | September 14, 2010 |
| Days to Decision | 105 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 |