Electrosurgical Patient Return Electrode
The Electrosurgical Patient Return Electrode (product code ODR) is a general and plastic surgery device used as a ground pad to complete the electrosurgical circuit during surgery. It is a single-use, non-sterile dispersive electrode with a pre-attached cord designed to adhere to the patient over the entire pad surface, ensuring safe return of electrosurgical current from the active electrode to the generator. This device is FDA Class 2 under regulation 878.4400 in the General, Plastic Surgery specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- ODR
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K160366 | Electrosurgical disposable grounding pads | Aug 19, 2016 | Substantially Equivalent | Top-Rank Health Care Co., Ltd. |
| K121268 | WANDY DISPERSVIE ELECTRODE | Dec 20, 2012 | Substantially Equivalent | Bio-Med USA, Inc. |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | Aug 13, 2008 | Substantially Equivalent | Ventlab Corp. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.