510(k) K082204
K082204 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "SERIES SY DISPOSABLE ELECTROSURGICAL PAD". The FDA issued a decision of Substantially Equivalent on August 13, 2008. The device falls under product code ODR (Electrosurgical Patient Return Electrode), a Class II device regulated under 21 CFR 878.4400. Ventlab Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2008
- Date Received
- August 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.