Company · US
Gentuity, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2025. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2025 | K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter Gentuity, LLC | DQO |
| Aug 16, 2024 | K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) Gentuity, LLC | NQQ |
| Aug 8, 2023 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Gentuity, LLC | DQO |
| Feb 20, 2020 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter Gentuity, LLC | NQQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2026 | Gentuity, LLC Gentuity HF-OCT Imaging System Model G10-01;
Software version 23.2.13; Open, Classified |
DQO | K242966 |