Company ยท US
Elucent Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 2026 | K260565 | SmartClip Delivery Catheter (ADR-1715) Elucent Medical | EOQ |
| Dec 20, 2024 | K233639 | SmartClip Secure Soft Tissue Marker Elucent Medical, Inc. | NEU |
| Mar 22, 2019 | K183400 | EnVisio Navigation Sytem Elucent Medical, Inc. | NEU |
| Jun 4, 2018 | K180640 | SmartClip Soft Tissue Marker Elucent Medical, Inc. | NEU |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2025 | Elucent Medical Inc EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS
Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a med Open, Classified |
NEU | K183400 |