K925708 is an FDA 510(k) clearance for the DISPOSABLE ELECTROSURGERY BALL ELECTRODE. This device is classified as a Electrosurgical Device (Class II - Special Controls, product code DWG).
Submitted by Beacon Laboratories, Inc. (Broomfield, US). The FDA issued a Cleared decision on April 20, 1993, 159 days after receiving the submission on November 12, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K925708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1992 |
| Decision Date | April 20, 1993 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | DWG — Electrosurgical Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |