Sheridan Electrosurgery Protection Filter
510(k) K881293
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881293 | Date16 Jun 1988 | 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- Withdrawn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
- BZT
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1920
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Sheridan Electrosurgery Protection Filter is a device designed to filter and attenuate electrical currents generated during electrosurgical procedures, helping to protect patients and equipment from unintended electrical discharge. It functions as a protective barrier within the electrosurgical circuit, ensuring safe delivery of energy to the surgical site.
The filter is classified as a Class II medical device (product code BZT) and received FDA 510(k) clearance (K881293) on June 16, 1988 with a traditional clearance pathway and a decision of substantially equivalent. It is supplied by Sheridan Catheter Corp. and is intended for use in anesthesiology settings, complying with the applicable regulatory requirements for a Class II device.
Other devices from Sheridan Catheter Corp.
Questions
AI-generated answers, 24 Sep 2026
What is the Sheridan Electrosurgery Protection Filter used for?
The Sheridan Electrosurgery Protection Filter is designed to filter and attenuate electrical currents generated during electrosurgical procedures, helping to protect patients and equipment from unintended electrical discharge by acting as a protective barrier within the electrosurgical circuit.
How is the Sheridan Electrosurgery Protection Filter supplied and is it reusable?
The device is supplied by Sheridan Catheter Corp. The provided data does not specify whether it is single-use or reusable, so reuse status cannot be determined from the available information.
What regulatory pathway and classification apply to the Sheridan Electrosurgery Protection Filter?
The Sheridan Electrosurgery Protection Filter is classified as a Class II medical device with product code BZT and received FDA 510(k) clearance (K881293) via a traditional pathway on June 16, 1988, based on a determination of substantial equivalence.