FDA applicant

Urohealth, Inc.

Costa Mesa, CA1 decision1997–19970 recalls

FDA records 1 decision for Urohealth, Inc. (Costa Mesa, CA) in 1997: 1 510(k) clearance. All are in product code FCW (Light Source, Fiberoptic, Routine). Its devices cite 2 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 Urohealth, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Urohealth, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Urohealth”

FDA records each applicant name separately; these may or may not be the same firm.

Urohealth Systems, Inc. 3

Urohealth, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Urohealth”