Spinal Needle XN254-22
Spinal Needle XN254-22 is a Class II device made by Hakko Co., Ltd., cleared under FDA 510(k) K961151 on 19 Mar 1997 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04526737170510), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04526737170510 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961151 | Date19 Mar 1997 | StatusActive |
Official records
- AccessGUDID record 04526737170510
- FDA 510(k) database K961151
Across registries
- FDA 510(k) K961151 decided 19 Mar 1997 Active
- FDA GUDID UDI-DI 04526737170510 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K961151
- Listed FDA GUDID 04526737170510
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spinal Needle
- Generic name
- Peripheral nerve-block sharp needle
- Model / reference
- XN254-22
- Description
- 22G x 10"(254mm) Metal hub With 1cm calibrations, depth guide
- Primary DI / UDI-DI
- 04526737170510
- 510(k) Number
- FDA product code
- BSP
- GMDN term
- Peripheral nerve-block sharp needle
- Device class
- Class II
- Regulation number
- 868.5150
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 22 GaugeLength — 254 Millimeter
Similar devices
Other devices filed under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)).
- Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit by Solo-Dex, Inc
- Dr J Spinal and Epidural Needles by DR.JAPAN CO., LTD.
- Plexufix Brachial Plexus Anesth Needle by Burron Medical Products, Inc.
- Gertie Marx Needle by Intl. Medical-Dental Products USA, Inc.
- PHOENIX EPIDURAL & SPINAL NEEDLES by MYCO MEDICAL SUPPLIES INC.
- Dr Japan Facil Point Spinal Needle by Myco Medical, Inc.
- Vygon Spinal Anesthesia Needle W/Introducer 183 by Vygon Corp.
- Curity Calibrated Tuohy Type Epidural Needle by Kendall Healthcare Products Co. Div.Of Tyco Health
- Tuohy NRFit by Pajunk GmbH Medizintechnologie
- PENCAN SPINAL NEEDLE by B. Braun Medical, Inc.