ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
FDA 510(k) clearance K112945 · decided 2011-11-03
Clearance details
- K-number
- K112945
- Device name
- ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
- Applicant
- Inrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-04
- Decision date
- 2011-11-03
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm recall (Z-1671-2015) | Stryker Instruments Div. of Stryker Corporation | 2015-05-26 |