Spinal Needle XN203-25
Spinal Needle XN203-25 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 04526737170565), 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 | Number04526737170565 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961151 | Date19 Mar 1997 | StatusActive |
Official records
- AccessGUDID record 04526737170565
- FDA 510(k) database K961151
Across registries
- FDA 510(k) K961151 decided 19 Mar 1997 Active
- FDA GUDID UDI-DI 04526737170565 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K961151
- Listed FDA GUDID 04526737170565
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- Withdrawn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
- XN203-25
- Description
- 25G x 8"(203mm) Metal hub With 1cm calibrations, depth guide
- Primary DI / UDI-DI
- 04526737170565
- 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 — 25 GaugeLength — 203 Millimeter
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