K160366 is an FDA 510(k) clearance for the Electrosurgical disposable grounding pads. This device is classified as a Electrosurgical Patient Return Electrode (Class II - Special Controls, product code ODR).
Submitted by Top-Rank Health Care Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on August 19, 2016, 192 days after receiving the submission on February 9, 2016.
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 | K160366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2016 |
| Decision Date | August 19, 2016 |
| Days to Decision | 192 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. |