Class Class II
Sterilization Pouch and Roll (K243179)
Description
Sterilization Pouch and Roll by Yichang Xinxin Paper Products Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243179
Clearance Date2025-06-26
Clearance TypeTraditional
Product CodeFRG
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243179
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. Sterilization Pouch and Roll (K243179) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | 2018 |
Trace the full predicate network for K243179
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.