Class Class II
ExpressCore Biopsy Device (K243886)
Description
ExpressCore Biopsy Device by Inrad, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243886
Clearance Date2025-04-29
Clearance TypeTraditional
Product CodeKNW
Regulation Number876.1075
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243886
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ExpressCore Biopsy Device (K243886) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K112945 | ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18G... | Inrad, Inc. | 2011 |
| K090611 | REVOLUTION FULL CORE BIOPSY | Inrad | 2009 |
Trace the full predicate network for K243886
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.