K003403 is an FDA 510(k) clearance for the ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999, a Electrode, Electrosurgical (Class II — Special Controls, product code JOS), submitted by Highland / Marietta, Inc. (Mentor, US). The FDA issued a Cleared decision on May 7, 2001, 187 days after receiving the submission on November 1, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K003403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2000 |
| Decision Date | May 07, 2001 |
| Days to Decision | 187 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 |