Class Class II
Denudation Pipettes (K250838)
Description
Denudation Pipettes by Guangzhou Pinzhi Medical Device Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250838
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeMQH
Regulation Number884.6130
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250838
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. Denudation Pipettes (K250838) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited | 2017 |
Trace the full predicate network for K250838
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.