K993885 is an FDA 510(k) clearance for the ULTRABLATOR ELECTRODE, a Electrode, Electrosurgical (Class II — Special Controls, product code JOS), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on February 10, 2000, 86 days after receiving the submission on November 16, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K993885 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 16, 1999 |
| Decision Date | February 10, 2000 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JOS — Electrode, Electrosurgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |