Continuous Epidural Anesthesia Tray
510(k) K893938
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893938 | Date7 Aug 1989 | 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- Withdrawn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
- 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
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.
Other devices from Medsurg Industries, Inc.
Questions
AI-generated answers, 25 Sep 2026
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.