K121268 is an FDA 510(k) clearance for the WANDY DISPERSVIE ELECTRODE. This device is classified as a Electrosurgical Patient Return Electrode (Class II — Special Controls, product code ODR).
Submitted by Bio-Med USA, Inc. (Paterson, US). The FDA issued a Cleared decision on December 20, 2012, 238 days after receiving the submission on April 26, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Ground Pad Used To Finish Circuit During Electrosurgery. A Single Use, Non-sterile Dispersive Electrode With A Pre-attached Cord Used To Adhere To The Patient Over The Entire Pad Surface To Complete The Electrosurgical Circuit Between The Generator, The Active Electrode, And The Patient..
| 510(k) Number | K121268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2012 |
| Decision Date | December 20, 2012 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ODR — Electrosurgical Patient Return Electrode |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Ground Pad Used To Finish Circuit During Electrosurgery. A Single Use, Non-sterile Dispersive Electrode With A Pre-attached Cord Used To Adhere To The Patient Over The Entire Pad Surface To Complete The Electrosurgical Circuit Between The Generator, The Active Electrode, And The Patient. |