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Continuous Epidural Anesthesia Tray

by Spinal Specialties, Inc.

510(k) K944029

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)SESK Substantially Equivalent — Kit · Traditional NumberK944029 Date30 Jun 1995ClearedStatusActive

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  • Withdrawn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
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 26 Sep 2026

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

A continuous epidural anesthesia tray is a device used for the administration of anesthetic agents into the epidural space for pain management. It is classified as an anesthesia conduction kit under FDA regulations.

The tray is supplied as a sterile, single-use kit intended for use in clinical settings such as hospitals or surgical centers. It includes components necessary for epidural catheter placement and is authorized under FDA 510(k) clearance K944029.

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Questions

AI-generated answers, 26 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 primary use of this continuous epidural anesthesia tray?

    The tray is designed for the administration of anesthetic agents into the epidural space. It is intended for pain management and includes components necessary for epidural catheter placement.

  • Is the kit sterile and intended for single use?

    Yes, the tray is supplied as a sterile, single-use kit. It is intended for use in clinical settings such as hospitals or surgical centers.

  • What is the regulatory status of this device?

    This device is authorized under FDA 510(k) clearance, specifically K944029. It is classified as an anesthesia conduction kit.

  • Who is the manufacturer of this device?

    The device is manufactured by Spinal Specialties, Inc., located in San Antonio, Texas.