Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533)
Description
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus by Hlb Co., Ltd. Healthcare, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243533
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. Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine ... | Promisemed Hangzhou Meditech Co., Ltd. | 2022 |
Trace the full predicate network for K243533
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.