elucent.comSmartClip Secure Soft Tissue Marker
Elucent Medical, Inc.
ELUCENT MEDICAL INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014653199 | 3014653199 | ELUCENT MEDICAL INC. | 1 | N | 2026-01-01 | 6509 Flying Cloud Drive Suite 160 Eden Prairie MN US 55344 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00851674008034 | EnVisio - EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display | 844-417-1700 | Customerservice@elucent.com |
| 00851674008041 | EnVisio - Envisio Navigator and Calibration Disk | 844-417-1700 | Customerservice@elucent.com |
| 00851674008058 | EnVisio - Envisio Navigation Patient Pad | 844-417-1700 | Customerservice@elucent.com |
| 00851674008065 | EnVisio - EnVisio Navigation System Heads Up Display | 844-417-1700 | Customerservice@elucent.com |
| 10851674008000 | SmartClip - Soft Tissue Marker and Delivery System - PINK | 844-417-1700 | Customerservice@elucent.com |
| 10851674008017 | SmartClip - Soft Tissue Marker and Delivery System - GREEN | 844-417-1700 | Customerservice@elucent.com |
| 10851674008024 | SmartClip - Soft Tissue Marker and Delivery System - PURPLE | 844-417-1700 | Customerservice@elucent.com |
| 10851674008086 | SmartClip - Soft Tissue Marker and Delivery System - PINK (Revised Frequency) | 844-417-1700 | Customerservice@elucent.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 220006 | 1285477840 | K233639 | SmartClip Secure Soft Tissue Marker | NEU | 2024-12-20 |
| 220006 | 1118849787 | K183400 | EnVisio Navigation Sytem | NEU | 2019-03-22 |
| 220006 | 1874752718 | K180640 | SmartClip Soft Tissue Marker | NEU | 2018-06-04 |
| 220006 | 1508841592 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NEU | 3 | 2024-12-20 |
PMN#
EnVisio Navigation Sytem
Elucent Medical, Inc
SmartClip Soft Tissue Marker
Elucent Medical, Inc.
GUDID#
EnVisio - EnVisio Navigation System Heads Up Display
2019-04-15
EnVisio - Envisio Navigation Patient Pad
2019-04-15
EnVisio - Envisio Navigator and Calibration Disk
2019-04-15
EnVisio - EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display
2019-04-15
SmartClip - Soft Tissue Marker and Delivery System - PURPLE
2018-07-17
SmartClip - Soft Tissue Marker and Delivery System - GREEN
2018-07-17
SmartClip - Soft Tissue Marker and Delivery System - PINK
2018-07-17
SmartClip - Soft Tissue Marker and Delivery System - PINK (Revised Frequency)
2020-01-27
EnVisio - EnVisio Navigation System Heads Up Display
2020-08-07
EnVisio - Screenless version of the Envisio Navigator and Calibration Disk
2020-08-07
EnVisio - EnVisio Navigation System Heads Up Display Version 2
2020-12-15
EnVisio - Screenless version of the Envisio Navigator and SmartCal Calibration Disk
2023-03-13
EnVisio - Envisio Navigation Patient Pad - RF Sponge Detection Compatible
2023-03-24
EnVisio System - EnVisio System including the following components: SmartSurface, foot pedal and heads-up display
2025-02-04
SmartSensor - EnVisio System SmartSensor & SmartCal Calibration Disk
2025-03-31
SmartClip Secure - Soft Tissue Marker and Delivery System - Purple
2025-06-01
SmartClip Secure - Soft Tissue Marker and Delivery System - Green
2025-06-01
SmartClip Secure - Soft Tissue Marker and Delivery System - Pink
2025-06-01
SmartClip Lite - Eval Kit - SmartClip Lite- Evaluation Kit
2026-02-25
SmartClip Secure - Soft Tissue Marker and Delivery System - Violet (T-Lock)
2026-02-16
SmartClip - Soft Tissue Marker and Delivery System - Violet, 10 cm (T-Lock)
2026-02-16
SmartClip - Soft Tissue Marker and Delivery System - Violet, 7.5 cm (T-Lock)
2026-02-16
SmartClip - Soft Tissue Marker and Delivery System - Violet, 5 cm (T-Lock)
2026-02-16
SmartClip - Soft Tissue Marker and Delivery System - Green, 10 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Green, 7.5 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Green, 5 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Purple, 10 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Purple, 7.5 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Purple, 5 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Pink, 10 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Pink, 7.5 cm (T-Lock)
2025-10-01
SmartClip - Soft Tissue Marker and Delivery System - Pink, 5 cm (T-Lock)
2025-10-01
SmartClip - Soft tissue marker and delivery system, Purple, 10cm
2022-11-04
SmartClip - Soft tissue marker and delivery system, Purple, 7.5cm
2022-11-04
SmartClip - Soft tissue marker and delivery system, Purple, 5cm
2022-11-04
SmartClip - Soft tissue marker and delivery system - Green, 10cm
2022-11-04
SmartClip - Soft tissue marker and delivery system - Green, 7.5cm
2022-11-04
SmartClip - Soft tissue marker and delivery system - Green, 5cm
2022-11-04
SmartClip - Soft tissue marker and delivery system - Pink, 10cm
2022-11-04
SmartClip - Soft tissue marker and delivery system - Pink, 7.5cm
2022-11-04