Sonopsy-C1 SON2150
Sonopsy-C1 SON2150 is a Class II device made by Hakko Co., Ltd., cleared under FDA 510(k) K013109 on 12 Mar 2002 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04526737120041), 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 | Number04526737120041 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013109 | Date12 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 04526737120041
- FDA 510(k) database K013109
Across registries
- FDA 510(k) K013109 decided 12 Mar 2002 Active
- FDA GUDID UDI-DI 04526737120041 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K013109
- Listed FDA GUDID 04526737120041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sonopsy-C1
- Generic name
- Soft-tissue biopsy needle, single-use
- Model / reference
- SON2150
- Description
- 1 21G x 50mm biopsy needle with suction syringe 3 Filter paper
- Primary DI / UDI-DI
- 04526737120041
- 510(k) Number
- FDA product code
- FCG
- GMDN term
- Soft-tissue biopsy needle, single-use
- Device class
- Class II
- Regulation number
- 876.1075
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 21 GaugeLength — 50 Millimeter
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