Gentuity, LLC
Gentuity, LLC holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2025, with 1 FDA device recall on record.
Top product codes for Gentuity, LLC
FDA recalls by Gentuity, LLC
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Gentuity, LLC
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
- K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
- K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
- K192922 — Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.