Elucent Medical Inc
Eden Prairie, MN, US
ELUCENT MEDICAL INC. appears in FDA device records in Eden Prairie, MN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Elucent Medical Inc between 2018 and 2026. The busiest year on record is 2018, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260565 | SmartClip Delivery Catheter (ADR-1715) | EOQ | Substantially Equivalent | |
| K233639 | SmartClip Secure Soft Tissue Marker | NEU | Substantially Equivalent | |
| K183400 | EnVisio Navigation Sytem | NEU | Substantially Equivalent | |
| K180640 | SmartClip Soft Tissue Marker | NEU | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014653199 | 3014653199 | ELUCENT MEDICAL INC. | 6509 Flying Cloud Drive, Eden Prairie, MN 55344 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0806-2025 | 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 medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery. | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain