Class Class II
Endoscopic Injection Needles (K240675)
Description
Endoscopic Injection Needles by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240675
Clearance Date2024-10-04
Clearance TypeTraditional
Product CodeFBK
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240675
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. Endoscopic Injection Needles (K240675) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021 |
Trace the full predicate network for K240675
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.