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
Rx
false
OTC
false
Sterile
false
Single use
false

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
Electromagnetic surgical navigation/tracking systemAn assembly of devices intended for tracking spatial markers attached to a surgical instrument(s) and/or the patient, based on movement through a variable electromagnetic (EM) field. It is designed to generate visual diagrams of the relative position/orientation of the instrument/marker during surgery and may additionally allow surgical navigation through overlay of radiological images [e.g., ultrasound (US)]. It consists of a console with display and an EM field generator/receiver; spatial markers, instruments, a foot switch, or trolley may in addition be packaged with the system. It is intended for use during multiple types of surgical procedure (e.g., breast, gastrointestinal, lung).

Contacts#

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

Regulatory Flags#

DUNS number
079322481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851674008611EnVisio System SmartSensor and SmartCal DiskEnVisio System SmartSensor and SmartCal DiskSmartSensor2026-08-05
10851674008642SmartClipSMARTCLIPLT-YLW-5SMARTCLIPLT-YLW-52026-07-08
10851674008659SmartClipSMARTCLIPLT-YLW-7.5SMARTCLIPLT-YLW-7.52026-07-08
10851674008666SmartClipSMARTCLIPLT-YLW-10SMARTCLIPLT-YLW-102026-07-08
10851674008093SmartClipSMARTCLIP LITE, PINK, 5CMSMARTCLIPLT-PNK-52022-11-04
10851674008130SmartClipSMARTCLIP LITE, GREEN, 5CMSMARTCLIPLT-GRN-52020-04-13
10851674008147SmartClipSMARTCLIP LITE, PINK, 5CMSMARTCLIPLT-PNK-52020-04-13
10851674008154SmartClipSMARTCLIP LITE, PINK, 7.5CMSMARTCLIPLT-PNK-7.52020-04-13
10851674008161SmartClipSMARTCLIP LITE, PINK, 10CMSMARTCLIPLT-PNK-102020-04-13
10851674008178SmartClipSMARTCLIP LITE, GREEN, 7.5CMSMARTCLIPLT-GRN-7.52020-04-13
10851674008185SmartClipSMARTCLIP LITE, GREEN, 10CMSMARTCLIPLT-GRN-102020-04-13
10851674008192SmartClipSMARTCLIP LITE, PURPLE, 5CMSMARTCLIPLT-PURP-52020-04-13
10851674008208SmartClipSMARTCLIP LITE, PURPLE, 7.5CMSMARTCLIPLT-PRP-7.52020-04-13
10851674008215SmartClipSMARTCLIP LITE, PURPLE, 10CMSMARTCLIPLT-PURP-102020-04-13
10851674008253SmartClipSMARTCLIP LITE, PINK, 7.5CMSMARTCLIPLT-PNK-7.52022-11-04
10851674008260SmartClipSMARTCLIP LITE, PINK, 10CMSMARTCLIPLT-PNK-102022-11-04
10851674008277SmartClipSMARTCLIP LITE, GREEN, 5CMSMARTCLIPLT-GRN-52022-11-04
10851674008284SmartClipSMARTCLIP LITE, GREEN, 7.5CMSMARTCLIPLT-GRN-7.52022-11-04
10851674008291SmartClipSMARTCLIP LITE, GREEN, 10CMSMARTCLIPLT-GRN-102022-11-04
10851674008307SmartClipSMARTCLIP LITE, PURPLE, 5CMSMARTCLIPLT-PURP-52022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103653HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2026-07-07
00841911102939HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103110HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103554HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103561HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103578HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103523HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103547HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103479HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103486HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103493HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103509HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103516HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103370HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103387HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103394HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103400HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103417HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103424HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103431HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103448HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103455HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103462HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103318HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103325HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103332HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103349HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103356HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103363HydroMarkDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01