SERIES SY DISPOSABLE ELECTROSURGICAL PAD
FDA 510(k) clearance K082204 · decided 2008-08-13
Clearance details
- K-number
- K082204
- Device name
- SERIES SY DISPOSABLE ELECTROSURGICAL PAD
- Applicant
- Ventlab Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-05
- Decision date
- 2008-08-13
- Days to decision
- 8 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
- Crofton, MD, US
- Third-party review
- Yes
- 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 |
| WANDY DISPERSVIE ELECTRODE (K121268) | Bio-Med USA, Inc. | 2012-12-20 |
Recalls involving this device
No recalls on record reference this clearance.