K002463 is an FDA 510(k) clearance for the STELLAR, a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY), submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on November 8, 2000, 90 days after receiving the submission on August 10, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K002463 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 10, 2000 |
| Decision Date | November 08, 2000 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSY — Light, Surgical, Ceiling Mounted |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |