Class Class II
Verisafe Safety sterile needles (K222271)
Description
Verisafe Safety sterile needles by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222271
Clearance Date2023-02-15
Clearance TypeTraditional
Product CodeFMI
Regulation Number880.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222271
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. Verisafe Safety sterile needles (K222271) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K123684 | SOL-CARE SAFETY NEEDLE | Sol-Millennium Medical | 2013 |
Trace the full predicate network for K222271
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.