K011515 is an FDA 510(k) clearance for the MEDLINE GROUNDING PAD. This device is classified as a Electrode, Electrosurgical (Class II - Special Controls, product code JOS).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 13, 2001, 57 days after receiving the submission on May 17, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K011515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2001 |
| Decision Date | July 13, 2001 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | JOS — Electrode, Electrosurgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |