# Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (K260708): 510(k) cleared for Vein 360

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260708 |
| Device | Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) |
| Applicant | Vein 360 |
| Specialty / panel | Gastroenterology, Urology |
| Product code | FGB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-04 |
| Decision date | 2026-10-20 |
| Review time (days) | 230 |
| Third-party review | No |
| Applicant location | Cincinnati, OH, US |

## Why this score
- 230-day review, longer than typical.
- Posted 16 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260708). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.