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Sheridan Electrosurgery Protection Filter

by Sheridan Catheter Corp.

510(k) K881293

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881293 Date16 Jun 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.