Inrad
Medical device manufacturer in Kentwood, MI.
15510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243886 | ExpressCore Biopsy DeviceKNW · Traditional | 04/29/2025SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | 11/07/2024SE |
| K183503 | EasyMark Tissue MarkerNEU · Traditional | 10/17/2019SE |
| K112945 | Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, With/Hilitier 18GAX10CM…KNW · Special | 11/03/2011SE |
| K093399 | Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520KNW · Traditional | 11/19/2009SE |
| K093256 | Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018KNW · Traditional | 11/17/2009SE |
| K090611 | Revolution Full Core BiopsyKNW · Traditional | 06/04/2009SE |
| K063238 | Ultraclip II Wing and Ultraclip II CoilNEU · Traditional | 01/30/2007SE |
| K042341 | Ultraclip II USNEU · Special | 09/20/2004SE |
| K041201 | Ultraclip II MRGDW · Special | 06/03/2004SE |
| K000612 | Accucore Single Action Core Biopsy DeviceKNW · Traditional | 04/24/2000SE |
| K993785 | Ultraclip Tissue MarkerGDW · Traditional | 02/04/2000SE |
| K981721 | C0-AXIAL Introducer NeedleKNW · Traditional | 07/28/1998SE |
| K981166 | Accucore Core Biopsy Needle Catalog CODES:581014, 581614, 581618, 582018, 582518…KNW · Traditional | 06/22/1998SE |
| K980587 | IV Decanter-FlexibleLHI · Traditional | 04/17/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1063-2011 | Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2…This lot of product has the wrong expiration date on the carton label. The pouches contained the correct… | 12/20/2010Terminated |