WANDY DISPERSVIE ELECTRODE
FDA 510(k) clearance K121268 · decided 2012-12-20
Clearance details
- K-number
- K121268
- Device name
- WANDY DISPERSVIE ELECTRODE
- Applicant
- Bio-Med USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-26
- Decision date
- 2012-12-20
- Days to decision
- 238 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
- Paterson, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Electrosurgical disposable grounding pads (K160366) | Top-Rank Health Care Co., Ltd. | 2016-08-19 |
| SERIES SY DISPOSABLE ELECTROSURGICAL PAD (K082204) | Ventlab Corp. | 2008-08-13 |
Recalls involving this device
No recalls on record reference this clearance.