510(k) Report

FDA applicant

Uro-1, Inc.

Winston Salem, NC3 decisions2018–20220 recalls

FDA records 3 decisions for Uro-1, Inc. (Winston Salem, NC) from 2018 to 2022: 3 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FBK (Endoscopic Injection Needle…). Its devices cite 3 predicates, 0 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 Uro-1, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12021: 12022: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

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Which product codes does it file in?

  • KNWInstrument, Biopsy2decisions
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180214Repris Bladder Injection SystemUro-1, Inc. · 20181cites it

What has FDA decided for it lately?

  • K220611SUREcore Plus Biopsy InstrumentUro-1, Inc. · 2022
  • K201650VMCore Biopsy NeedleUro-1, Inc. · 2021
  • K180214Repris Bladder Injection SystemUro-1, Inc. · 2018

All 3 as Uro-1, Inc. →