510(k) Report

FDA applicant

Iconocare Health

Scottsdale, AZ2 decisions2022–20250 recalls

FDA records 2 decisions for Iconocare Health (Scottsdale, AZ) from 2022 to 2025: 2 510(k) clearances. All are in product code QSM (System, Surgical, Computer Controlled…). Its devices cite 7 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 Iconocare Health’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Iconocare Health by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K2426108mm Monopolar Curved Scissors (470179)Iconocare Health · 2025
  • K2104788mm Monopolar Curved ScissorsIconocare Health · 2022

All 2 as Iconocare Health →