510(k) Report

FDA applicant

Uros Corp.

San Diego, CA1 decision1996–19960 recalls

FDA records 1 decision for Uros Corp. (San Diego, CA) in 1996: 1 510(k) clearance. All are in product code GEH (Unit, Cryosurgical, Accessories). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Uros Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Uros Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Uros Corp.’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?

  • GEHUnit, Cryosurgical, Accessories1decision

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.

  • K960387Urosprobe System, Model 1000Uros Corp. · 19961cites it

What has FDA decided for it lately?

  • K960387Urosprobe System, Model 1000Uros Corp. · 1996

The one decision as Uros Corp. →