EnVisio
The FDA filing describes the EnVisio Navigation System as detecting SmartClip soft-tissue markers and providing real-time three-dimensional navigation during surgery. It acquires and…
The FDA filing describes the EnVisio Navigation System as detecting SmartClip soft-tissue markers and providing real-time three-dimensional navigation during surgery.
It acquires and analyzes electromagnetic signatures to display the relative distance, depth, and direction from the electrosurgical tool tip to implanted markers.
Listed Item
EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display
Device Description and Stated Use
The summary identifies its intended role as detecting and navigating to an implanted SmartClip in an intraoperative guided surgical procedure. System equipment includes a console, heads-up display, patient pad, and foot pedal.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Elucent Medical Inc., United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K183400 |
| Record published | 2020-08-07 |
| Record revised | 2024-02-01 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2025-03-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENVISIO-SYS | In distribution | |
| ENVISIO-HUD2 | Withdrawn | |
| NAV-SLIM | Withdrawn | |
| NAV-PENCIL | Withdrawn | |
| ENVISIO-HUD2 | Withdrawn | |
| ENVISIO-PP1 | Withdrawn | |
| ENVISIO-HUD1 | Withdrawn | |
| NAV-SLIM | Withdrawn | |
| ENVISIO-PP1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydroMARK | Devicor Medical Products, Inc. | 75 |
| Scout® | Merit Medical Systems, Inc. | 68 |
| Scout MD™ | Merit Medical Systems, Inc. | 46 |
| SmartClip | Elucent Medical Inc. | 37 |
| BiomarC® | Carbon Medical Technologies, Inc. | 25 |
| HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 21 |
| SecurMark | Hologic, Inc. | 15 |
| Gold Marker | Riverpoint Medical LLC | 15 |
| MammoStar™ | Carbon Medical Technologies, Inc. | 15 |
| SecurMark for Atec | Hologic, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| TriMark | Hologic, Inc. | 14 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233639 | 2024-12-20 |
| K183400 | 2019-03-22 |
| K180640 | 2018-06-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Elucent Medical Inc. | 510(k) number | 2024-11-18 | Class II | Device Design | 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. | 283 (48 units) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.