K000079 is an FDA 510(k) clearance for the NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M, a Apparatus, Electrosurgical (Class II — Special Controls, product code HAM), submitted by Nikomed U.S.A., Inc. (Stillwater, US). The FDA issued a Cleared decision on February 4, 2000, 24 days after receiving the submission on January 11, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K000079 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 11, 2000 |
| Decision Date | February 04, 2000 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HAM — Apparatus, Electrosurgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |