MACROLYTE DISPERSIVE ELECTRODE
FDA 510(k) clearance K120476 · decided 2012-06-12
Clearance details
- K-number
- K120476
- Device name
- MACROLYTE DISPERSIVE ELECTRODE
- Applicant
- Conmed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-02-16
- Decision date
- 2012-06-12
- Days to decision
- 117 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Conmed Corporation
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is app recall (Z-1719-2014) | ConMed Corporation | 2014-06-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ConMed PadPro Multifunction Electrodes (P200004/S001) | Conmed Corporation | 2022-06-16 |
| ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters (P200004) | Conmed Corporation | 2021-09-26 |