510(k) Report

FDA applicant

Claria Medical, Inc.

Mountain View, CA1 decision2026–20260 recalls

FDA records 1 decision for Claria Medical, Inc. (Mountain View, CA) in 2026: 1 De Novo grant. All are in product code SIM (Gynecologic Power Morcellator And Containment…). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Claria Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Claria Medical, 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

Which product codes does it file in?

  • SIMGynecologic Power Morcellator And Containment System1decision

What has FDA decided for it lately?

  • DEN250034Claria SystemClaria Medical, Inc. · 2026

The one decision as Claria Medical, Inc. →