Class Class II
F88 URE-SD/RD Flexible Ureteroscope (K243894)
Description
F88 URE-SD/RD Flexible Ureteroscope by Sg Endoscopy Pte, Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243894
Clearance Date2025-05-02
Clearance TypeTraditional
Product CodeFGB
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243894
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. F88 URE-SD/RD Flexible Ureteroscope (K243894) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141250 | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2014 |
Trace the full predicate network for K243894
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.