Electrosurgical disposable grounding pads
FDA 510(k) clearance K160366 · decided 2016-08-19
Clearance details
- K-number
- K160366
- Device name
- Electrosurgical disposable grounding pads
- Applicant
- Top-Rank Health Care Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-09
- Decision date
- 2016-08-19
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- ODR
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shaoxing, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Top-Rank Health Care Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WANDY DISPERSVIE ELECTRODE (K121268) | Bio-Med USA, Inc. | 2012-12-20 |
| SERIES SY DISPOSABLE ELECTROSURGICAL PAD (K082204) | Ventlab Corp. | 2008-08-13 |
Recalls involving this device
No recalls on record reference this clearance.