Class Class II
EGIS Biliary Double Bare Stent (BDB080405) (K242845)
Description
EGIS Biliary Double Bare Stent (BDB080405) by S&G Biotech, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242845
Clearance Date2025-06-25
Clearance TypeTraditional
Product CodeFGE
Regulation Number876.5010
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242845
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. EGIS Biliary Double Bare Stent (BDB080405) (K242845) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | 2023 |
Trace the full predicate network for K242845
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.