Epineed Epidural Needle
510(k) K832233
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832233 | Date8 Aug 1983 | 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- Withdrawn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
- BSP
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5150
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Epineed Epidural Needle is a Needle, Conduction, Anesthetic (with or without Introducer), designed for epidural anesthesia procedures. It facilitates the administration of local anesthetics or other therapeutic agents into the epidural space for pain management or surgical anesthesia, ensuring precise needle placement with minimal tissue trauma.
This device is supplied as a single-use, sterile instrument and is classified under FDA product code BSP as a Class II medical device with special controls. It is intended for use in clinical settings by trained healthcare professionals, such as anesthesiologists, and requires proper handling and disposal per regulatory guidelines. The clearance (K832233) was issued under the FDA 510(k) program in 1983, with no additional regulatory status implied beyond the stated authorization.
Other devices from Terumo Medical Corporation
Questions
AI-generated answers, 19 Sep 2026
What is the primary use of the Epineed Epidural Needle in clinical practice?
The Epineed Epidural Needle is specifically designed for epidural anesthesia procedures. It is used by trained healthcare professionals, such as anesthesiologists, to administer local anesthetics or therapeutic agents into the epidural space. This facilitates pain management or surgical anesthesia by ensuring precise needle placement with minimal tissue trauma.
Is the Epineed Epidural Needle intended for single-use or can it be reused?
The Epineed Epidural Needle is explicitly supplied as a single-use, sterile instrument. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.
How is the Epineed Epidural Needle regulated, and what does that mean for its use?
The Epineed Epidural Needle is classified as a Class II medical device under the FDA’s product code BSP and has received 510(k) clearance (K832233). This means it has been evaluated and determined to be substantially equivalent to a legally marketed device, ensuring it meets FDA safety and effectiveness standards. It is intended for use in clinical settings by trained professionals, adhering to regulatory guidelines for handling and disposal.
Are there different sizes or models of the Epineed Epidural Needle, and how can I identify them?
The Epineed Epidural Needle comes in multiple models, each identified by unique registration numbers (e.g., 3030626857, 1018233, etc.). These models are listed under the FDA’s openFDA database, but the exact specifications (e.g., gauge, length) are not detailed in the provided data. For precise sizing or model selection, refer to the manufacturer’s product catalog or packaging.
How should the Epineed Epidural Needle be stored to maintain its sterility?
Since the Epineed Epidural Needle is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for storage conditions, which typically include protection from contamination and physical damage to preserve sterility.