Class Class II
ClearTip FNA and FNB Types (K250994)
Description
ClearTip FNA and FNB Types by Finemedix Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250994
Clearance Date2025-08-21
Clearance TypeTraditional
Product CodeFCG
Regulation Number876.1075
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250994
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. ClearTip FNA and FNB Types (K250994) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231267 | ClearTip | Finemedix Co., Ltd. | 2023 |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | 2018 |
Trace the full predicate network for K250994
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.