Disposable Patient Return Electrode
by Erbe USA, Inc. 510(k)
Active
510(k) K960569
Overview
A disposable patient return electrode is a device that functions as a grounding pad for high-frequency electrosurgical current, completing the electrical circuit between the patient and the electrosurgical generator to prevent thermal injury at the return site. It is used in surgical settings for cutting and coagulation of human tissue when used in conjunction with electrosurgical generators.
The electrode is supplied sterile and intended for single-use only. It is compatible with Erbe and third-party electrosurgical generators, including those with and without return electrode safety systems. The device is authorized under FDA 510(k) clearance (K960569) and is used by surgeons or surgical staff in operative environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960569 | Date11 Mar 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Erbe USA, Inc.
Questions
What is the disposable patient return electrode used for?
It functions as a grounding pad for high-frequency electrosurgical current, completing the electrical circuit between the patient and the generator to prevent thermal injury at the return site during cutting and coagulation of human tissue.
Is the electrode sterile and intended for single-use only?
Yes, the device is supplied sterile and is designed for single-use only, meaning it should not be reprocessed or reused after a procedure to maintain safety and effectiveness.
Which electrosurgical generators is this electrode compatible with?
It is compatible with both Erbe and third-party electrosurgical generators, including models with and without return electrode safety monitoring systems.
What regulatory authorization does this device have?
The device is authorized under FDA 510(k) clearance (K960569) and was found substantially equivalent to a predicate device, allowing its legal marketing in the United States.