Class Class II
Resolv Endoscopic Hemostat System (K234131)
Description
Resolv Endoscopic Hemostat System by Hemostasis, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234131
Clearance Date2024-07-26
Clearance TypeTraditional
Product CodeQAU
Regulation Number878.4456
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234131
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. Resolv Endoscopic Hemostat System (K234131) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190677 | EndoClot | Endoclot Plus Co., Ltd. | 2021 |
| K122886 | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING | Hemostasis, LLC | 2012 |
Trace the full predicate network for K234131
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.