Electrosurgical Grounding Pad Cable
by Johnson & Johnson Professionals, Inc.
510(k) K780924
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780924 | Date22 Jun 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 21 Sep 2026
An electrosurgical grounding pad cable is a device used to connect a patient return electrode (grounding pad) to an electrosurgical generator, completing the electrical circuit during electrosurgical procedures. It facilitates the safe return of high-frequency electrical current from the patient to the generator, minimizing the risk of burns at the return electrode site.
This device is supplied as a reusable or single-use accessory depending on the specific model and manufacturer instructions, and is intended for use in general and plastic surgery settings. It does not have inherent MRI safety properties unless explicitly stated, and its use, storage, and handling should follow the manufacturer’s labeling. The device received FDA 510(k) clearance (K780924) on June 22, 1978, under product code GEI, and is classified as substantially equivalent to a predicate device.
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Questions
AI-generated answers, 21 Sep 2026
What is the electrosurgical grounding pad cable used for?
It connects a patient return electrode (grounding pad) to an electrosurgical generator, completing the electrical circuit during electrosurgical procedures to safely return high-frequency current from the patient to the generator and minimize burn risk at the return electrode site.
Is the electrosurgical grounding pad cable reusable or single-use?
It is supplied as either reusable or single-use depending on the specific model and manufacturer instructions, so users must consult the labeling for the particular version they are using to determine correct handling and disposal.
What regulatory clearance does the electrosurgical grounding pad cable have?
The device received FDA 510(k) clearance (K780924) on June 22, 1978, under product code GEI, and was determined to be substantially equivalent to a predicate device via the traditional 510(k) pathway.