Electrode, Model E7504 Prep II
510(k) K790296
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790296 | Date12 Apr 1979 | 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- Withdrawn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, 1 Oct 2026
The Electrode, Model E7504 Prep II is a patient return electrode designed for use in electrosurgical procedures. It facilitates the safe conduction of electrical current during surgery, ensuring proper grounding of the patient to prevent complications. Constructed from stainless steel, this device is intended for monopolar electrosurgical systems to assist in cutting and coagulation of tissues. Its design supports stable contact and effective current return during open surgical interventions.
This electrode is supplied as a single-use device, intended for use in general and plastic surgery settings. It requires no sterilization and is provided ready for immediate application. The device is classified under product code GEI and has been cleared by the FDA via a 510(k) Premarket Notification (K790296) under the Traditional review pathway. No additional regulatory markings or MRI safety considerations are specified in the available data.
Other devices from Valleylab, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the E7504 Prep II Electrode designed for?
The E7504 Prep II Electrode is specifically designed for use in monopolar electrosurgical procedures. It facilitates the safe conduction of electrical current during surgery by providing proper patient grounding, which helps prevent complications like burns or erratic current flow. This design ensures stable contact and effective current return, making it ideal for cutting and coagulation tasks in open surgical interventions.
Is the E7504 Prep II Electrode reusable or single-use?
The E7504 Prep II Electrode is intended for single-use only. It is supplied ready for immediate application, eliminating the need for sterilization or reprocessing. This design ensures hygiene and safety, as each electrode is used once and then discarded.
What surgical settings is the E7504 Prep II Electrode approved for?
This electrode is approved for use in general and plastic surgery settings. Its design supports stable electrical conduction during open surgical procedures, making it suitable for these specific applications where monopolar electrosurgery is commonly employed.
Does the E7504 Prep II Electrode require sterilization?
No, the E7504 Prep II Electrode does not require sterilization. It is supplied as a single-use device, pre-sterilized and ready for immediate use. This simplifies surgical workflows by reducing preparation time and ensuring consistent sterility for each procedure.
What material is the E7504 Prep II Electrode made from?
The E7504 Prep II Electrode is constructed from stainless steel. This material provides durability, conductivity, and corrosion resistance, ensuring reliable performance during electrosurgical procedures while maintaining patient safety.