Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G

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

510(k) Number

K090261 ↗

FDA Product Code

BSP

Device Class

Class II

Regulation

21 CFR Part 868.5150

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Smiths Medical Asd, Inc. →

• What is the Portex Tuohy Epidural Needle primarily used for in clinical settings?

  The Portex Tuohy Epidural Needle is designed specifically for epidural anesthesia procedures. Its Tuohy tip configuration allows for secure placement of a catheter within the epidural space, enabling regional analgesia or anesthesia delivery during surgical or labor/delivery scenarios.

• Are these needles reusable, and if not, why?

  No, the Portex Tuohy Epidural Needles are intended for single-use only. This is explicitly stated in the product description, as they are supplied sterile and must not be reused to maintain aseptic techniques and patient safety.

• What gauges and lengths are available for the Portex Tuohy Epidural Needle?

  The needles come in two gauges: 17G and 18G, with varying lengths such as 3.5 inches and 4.5 inches. These options allow clinicians to select the appropriate size based on patient anatomy and procedural requirements.

• How are these needles sterilized, and what precautions should be taken during storage?

  The needles are sterilized using ethylene oxide. Since they are sterile upon packaging and single-use, they must be stored in their original, sealed packaging to preserve sterility. Avoid exposure to moisture, extreme temperatures, or contamination before use.

• What regulatory pathway does the Portex Tuohy Epidural Needle follow, and who is the manufacturer?

  The Portex Tuohy Epidural Needle follows the FDA 510(k) clearance pathway, classified as a Class II medical device under the regulatory category for *Needle, Conduction, Anesthetic (With or Without Introducer)*. It is manufactured by Smiths Medical ASD, Inc. based in Keene, New Hampshire.