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ODRClass II

Electrosurgical Patient Return Electrode

21 CFR 878.4400 / General, Plastic Surgery
FDA source (opens on fda.gov)

ODR is the FDA product code for Electrosurgical Patient Return Electrode, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ODR
Device name
Electrosurgical Patient Return Electrode
FDA 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.
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code ODR

By decision year
3 clearances under product code ODR with a decision year between 2008 and 2016, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ODR by decision year
YearClearances
20081
20121
20161

Applicants with the most clearances

Product code ODR
Applicants holding the most 510(k) clearances under product code ODR
ApplicantClearances
Bio-Med USA, Inc.1
Top-rank Health Care Co.,Ltd.1
Salter Labs1

Companies listing this code with FDA

Companies whose registered establishments list this code