FDA.reportPublic FDA data

EnVisio System

Primary DI
00851674008553
Brand
EnVisio System
Company
Elucent Medical, Inc.
Model
ENVISIO-SYS
Device description
EnVisio System including the following components: SmartSurface, foot pedal and heads-up display
Published
2025-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183400000EnVisio Navigation SytemElucent Medical, Inc.2019-03-22NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851674008553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851674008553008516740085538516740085530851674008553

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-417-1700Customerservice@elucent.com

Regulatory Flags#

DUNS number
079322481
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851674008560SmartClip Lite - Eval KitSMARTCLIPLT-EVALKITSMARTCLIPLT-EVALKIT2026-02-25
10851674008574SmartClipSMARTCLIPLT-VLT-5 SMARTCLIPLT-VLT-5 2026-02-16
10851674008581SmartClipSMARTCLIPLT-VLT-7.5SMARTCLIPLT-VLT-7.52026-02-16
10851674008598SmartClipSMARTCLIPLT-VLT-10 SMARTCLIPLT-VLT-10 2026-02-16
10851674008604SmartClip SecureSMARTCLIP-SEC-VLTSMARTCLIP-SEC-VLT2026-02-16
00851674008577SmartClipSMARTCLIPLT-VLT-5 SMARTCLIPLT-VLT-5 2026-02-16
00851674008584SmartClipSMARTCLIPLT-VLT-7.5SMARTCLIPLT-VLT-7.52026-02-16
00851674008591SmartClipSMARTCLIPLT-VLT-10 SMARTCLIPLT-VLT-10 2026-02-16
00851674008607SmartClip SecureSMARTCLIP-SEC-VLTSMARTCLIP-SEC-VLT2026-02-16
00851674008034EnVisioENVISIO-SYSENVISIO-SYS2019-04-15
00851674008454SmartSensorSMARTSENSOR2025-03-31
10851674008468SmartClipSMARTCLIPLT-PINK-5SMARTCLIPLT-PINK-52025-10-01
10851674008475SmartClipSMARTCLIPLT-PNK-7.5SMARTCLIPLT-PNK-7.52025-10-01
10851674008482SmartClipSMARTCLIPLT-PINK-10SMARTCLIPLT-PINK-102025-10-01
10851674008499SmartClipSMARTCLIPLT-PURP-5SMARTCLIPLT-PURP-52025-10-01
10851674008505SmartClipSMARTCLIPLT-PURP-7.5SMARTCLIPLT-PURP-7.52025-10-01
10851674008512SmartClipSMARTCLIPLT-PURP-10SMARTCLIPLT-PURP-102025-10-01
10851674008529SmartClipSMARTCLIPLT-GRN-5SMARTCLIPLT-GRN-52025-10-01
10851674008536SmartClipSMARTCLIPLT-GRN-7.5SMARTCLIPLT-GRN-7.52025-10-01
10851674008543SmartClipSMARTCLIPLT-GRN-10SMARTCLIPLT-GRN-102025-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450435748SCOUT®MERIT MEDICAL SYSTEMS, INC.NEU2026-06-09
00884450767542SCOUT MD™Merit Medical Systems, Inc.NEU2026-06-09
00884450392850SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392867SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392874SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392881SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392935SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392942SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392959SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392966SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
10851674008574SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008581SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008598SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008604SmartClip SecureElucent Medical, Inc.NEU2026-02-16
10851674008468SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008475SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008482SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008499SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008505SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008512SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008529SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008536SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008543SmartClipElucent Medical, Inc.NEU2025-10-01
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
00801741226342UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
08719992742516Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22