Continuous Epidural Anesthesia Tray

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

Full name

Continuous Epidural Anesthes. Tray

510(k) Number

K840179 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Cavafix(R) Central Venous Catheter Kit W/Suture

  Class II

  FDA 510(k) K870403 Active Cleared 1 May 1987

• Perican, Epidural Cannula

  Class II

  FDA 510(k) K813179 Active Cleared 3 Dec 1981

• Bimeco Filtered Extension Set

  Class II

  FDA 510(k) K801605 Active Cleared 12 Aug 1980

• In-Stopper (Injection Cap

  Class II

  FDA 510(k) K813259 Active Cleared 31 Dec 1981

• Medifix

  Class II

  FDA 510(k) K813498 Active Cleared 7 Jan 1982

• Perfix Set for Epidural Anesthesia W/Tuo

  Class II

  FDA 510(k) K813186 Active Cleared 3 Dec 1981

See all devices from Burron Medical Products, Inc. →

• What is the Continuous Epidural Anesthesia Tray used for?

  The Continuous Epidural Anesthesia Tray is designed for administering continuous epidural anesthesia during surgical procedures or labor. It provides a sterile, organized assembly of components—including catheters, needles, connectors, and syringes—to facilitate precise placement of an epidural catheter and controlled infusion of local anesthetics or opioids. This setup helps minimize contamination risk while ensuring proper alignment and accessibility of instruments.

• How is the Continuous Epidural Anesthesia Tray supplied and what does it include?

  The tray is supplied in a sterile, sealed packaging to maintain sterility and safety. It includes all necessary components for epidural catheter placement and infusion, such as catheters, needles, connectors, and syringes, organized to ensure ease of use in sterile environments like operating rooms or delivery suites. This pre-assembled setup streamlines the procedure for trained anesthesiologists.

• Is the Continuous Epidural Anesthesia Tray single-use or reusable?

  The Continuous Epidural Anesthesia Tray is explicitly designed for single-use only. After initial use, the tray must not be reused to preserve sterility and safety standards. Reuse could compromise the integrity of the components and introduce contamination risks, which is why it is supplied in sterile packaging and intended for one-time use.

• What storage conditions are required for the Continuous Epidural Anesthesia Tray?

  The tray must be stored in a dry environment, protected from moisture and extreme temperatures. Proper storage ensures the integrity of the sterile packaging and the functionality of the components. Always follow the manufacturer’s instructions to maintain the device’s safety and performance until use.

• Are the components of the Continuous Epidural Anesthesia Tray MRI-safe?

  Yes, the components of the Continuous Epidural Anesthesia Tray are non-magnetic and MRI-safe for compatible imaging systems. This allows for safe use in MRI environments when indicated by the clinical procedure, reducing the risk of interference or injury during imaging.