510(k) K121268
K121268 is an FDA 510(k) premarket notification submitted by Bio-Med USA, Inc. for the device "WANDY DISPERSVIE ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 20, 2012. The device falls under product code ODR (Electrosurgical Patient Return Electrode), a Class II device regulated under 21 CFR 878.4400. Bio-Med USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2012
- Date Received
- April 26, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical Patient Return Electrode
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
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.