Asp ASPTSOLO25
by Sedatelec
Asp ASPTSOLO25 (110635), an acupuncture needle (FDA Class II; FDA product code MQX, Needle, Acupuncture, Single Use) made by Sedatelec, was cleared under FDA 510(k) K060392 on 26 Apr 2006 and listed in FDA GUDID on 22 Sep 2016 (UDI-DI 03760262490571); the registry lists it as not in commercial distribution (GUDID) 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 | Number03760262490571 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK060392 | Date26 Apr 2006 | StatusActive |
Official records
- AccessGUDID record 03760262490571
- FDA 510(k) database K060392
Across registries
- FDA 510(k) K060392 decided 26 Apr 2006 Active
- FDA GUDID UDI-DI 03760262490571 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K060392
- Listed FDA GUDID 03760262490571
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Asp
- Generic name
- Acupuncture needle, single-use
- Model / Ref / Catalog
- ASPTSOLO25, 110635
- Primary DI / UDI-DI
- 03760262490571
- 510(k) Number
- FDA product code
- MQX
- GMDN term
- Acupuncture needle, single-use
- Device class
- Class II
- Regulation number
- 880.5580
- GUDID distribution status
- Not in Commercial Distribution
- MRI safety
- MR Safe
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