Submission Details
| 510(k) Number | K011515 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
MEDLINE GROUNDING PAD
Jul 2001
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K011515 is an FDA 510(k) clearance for the MEDLINE GROUNDING PAD, 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 review panel. Regulated under 21 CFR 878.4400.
Device Classification
| Product Code | JOS — Electrode, Electrosurgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
Manufacturer
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