Class Class II
Sterile Syringes for Single Use (K223678)
Description
Sterile Syringes for Single Use by Shanghai Kindly Enterprise Development Group Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223678
Clearance Date2023-02-09
Clearance TypeTraditional
Product CodeFMF
Regulation Number880.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223678
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. Sterile Syringes for Single Use (K223678) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K103736 | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE | Dmc Medical, Ltd. | 2011 |
Trace the full predicate network for K223678
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.