Class Class II
Disposable Distal Attachment D-201 Series (K250296)
Description
Disposable Distal Attachment D-201 Series by Olympus Medical Systems Corp., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250296
Clearance Date2025-05-01
Clearance TypeTraditional
Product CodeFDS
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250296
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. Disposable Distal Attachment D-201 Series (K250296) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | 2026 |
Trace the full predicate network for K250296
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.