SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (K222944)
Description
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture by Safepath Medical, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222944
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. SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (K222944) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173747 | REXLENE | Sm Eng Co., Ltd. | 2018 |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | 2017 |
Trace the full predicate network for K222944
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.