510(k) Report

FDA applicant

Uroviu Corporation

Los Altos, CA7 decisions2018–20250 recalls

FDA records 7 decisions for Uroviu Corporation (Los Altos, CA) from 2018 to 2025: 7 510(k) clearances. All are in product code FAJ (Cystoscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 199 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Uroviu Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2018: 12019: 12021: 12024: 22025: 2
2018high 2 (2024) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Uroviu Corporation by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Uroviu Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FAJCystoscope And Accessories, Flexible/Rigid7decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 199 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 129 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171500Uro-V CystoscopeUroviu Corporation · 20182cite it
  • K232837Uro-G HD Flexible CystoscopeUroviu Corporation · 20242cite it
  • K202921Uro-G CystoscopeUroviu Corporation · 20211cites it

What has FDA decided for it lately?

  • K253226UV5000W HandleUroviu Corporation · 2025
  • K250797UV5000 HandleUroviu Corporation · 2025
  • K243196Uro-G HD Cystoscope (1520)Uroviu Corporation · 2024
  • K232837Uro-G HD Flexible CystoscopeUroviu Corporation · 2024
  • K202921Uro-G CystoscopeUroviu Corporation · 2021
  • K182876Uro-N CystoscopeUroviu Corporation · 2019
  • K171500Uro-V CystoscopeUroviu Corporation · 2018

All 7 as Uroviu Corporation →