Customed 712057831825
Customed 712057831825 (9000991825) is a Class II device made by Customed, Inc., cleared under FDA 510(k) K092338 on 27 May 2011 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M20890009918250), 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 | NumberM20890009918250 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092338 | Date27 May 2011 | StatusActive |
Official records
- FDA 510(k) database K092338
Across registries
- FDA 510(k) K092338 decided 27 May 2011 Active
- FDA GUDID UDI-DI M20890009918250 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092338
- Listed FDA GUDID M20890009918250
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Customed
- Generic name
- Soft-tissue biopsy needle, single-use
- Model / Ref / Catalog
- 712057831825, 9000991825
- Primary DI / UDI-DI
- M20890009918250
- 510(k) Number
- FDA product code
- KNW
- GMDN term
- Soft-tissue biopsy needle, single-use
- Device class
- Class II
- Regulation number
- 876.1075
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 250 MillimeterNeedle Gauge — 18 Gauge
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- Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm by Biopsybell S.R.L.