Disposable Lectroswitch, Model E2503
by Valleylab, Inc. 510(k)
Active
510(k) K781510
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781510 | Date24 Oct 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 24 Sep 2026
The Disposable Lectroswitch, Model E2503, is an electrosurgical device categorized for cutting and coagulation. It functions as an accessory within electrosurgical systems used in general and plastic surgery.
This device is supplied as a single-use, disposable instrument. It has received FDA 510(k) clearance under the product code GEI and is classified as a Class II medical device.
Other devices from Valleylab, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the primary clinical application for the Lectroswitch E2503?
The Lectroswitch E2503 is an electrosurgical accessory specifically designed to perform cutting and coagulation procedures. It is intended for use within electrosurgical systems during general and plastic surgery operations.
Is the Lectroswitch E2503 intended for multiple uses?
No, this device is supplied as a single-use, disposable instrument. It is designed to be used for one procedure and then discarded to ensure patient safety and maintain the integrity of the electrosurgical system.
What is the regulatory status of this device?
The Lectroswitch E2503 is classified as a Class II medical device and has received FDA 510(k) clearance under the product code GEI, confirming it is substantially equivalent to legally marketed predicate devices.