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Continuous Epidural Anesthesia Tray

by Medsurg Industries, Inc.

510(k) K893938

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 NumberK893938 Date7 Aug 1989ClearedStatusActive

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  • Withdrawn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
CAZ
Device Class
Class II
Regulation
21 CFR Part 868.5140
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Continuous Epidural Anesthesia Tray is a medical device used for administering continuous epidural anesthesia. It is designed to provide a controlled and sustained delivery of anesthetic agents to the epidural space, typically for pain management or surgical procedures.

The tray is supplied sterile and intended for single-use. It is not reusable and must be disposed of after use. The device is not MRI safe and should be stored in a dry, controlled environment. The device has received FDA 510(k) clearance under K893938.

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Questions

AI-generated answers, 25 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 Continuous Epidural Anesthesia Tray used for?

    It is a medical device used for administering continuous epidural anesthesia, providing a controlled and sustained delivery of anesthetic agents to the epidural space for pain management or surgical procedures.

  • Is the tray sterile and intended for single use?

    Yes, the tray is supplied sterile and is intended for single use. It is not reusable and must be disposed of after use.

  • How should the tray be stored?

    The tray should be stored in a dry, controlled environment. It is not MRI safe.

  • What is the regulatory status of this device?

    The Continuous Epidural Anesthesia Tray has received FDA 510(k) clearance under K893938.