Class Class II
GCI Sterilization Wrappers (K250321)
Description
GCI Sterilization Wrappers by George Courey, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250321
Clearance Date2025-06-06
Clearance TypeTraditional
Product CodeFRG
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250321
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. GCI Sterilization Wrappers (K250321) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172207 | Standard Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2017 |
Trace the full predicate network for K250321
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.