Class Class II
Utepreva Endometrial Sampler (UP01) (K240595)
Description
Utepreva Endometrial Sampler (UP01) by Utepreva, LLC, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240595
Clearance Date2024-08-14
Clearance TypeTraditional
Product CodeHFE
Regulation Number884.1100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240595
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. Utepreva Endometrial Sampler (UP01) (K240595) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | 2017 |
Trace the full predicate network for K240595
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.