FDA.reportPublic FDA data

ELUCENT MEDICAL INC.

Matched from indexed company URL: Elucent Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146531993014653199ELUCENT MEDICAL INC.1N2026-01-016509 Flying Cloud Drive Suite 160 Eden Prairie MN US 55344

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851674008560SmartClip Lite - Eval Kit - SmartClip Lite- Evaluation Kit844-417-1700customerservice@elucent.com
00851674008577SmartClip - Soft Tissue Marker and Delivery System - Violet, 5 cm (T-Lock)844-417-1700customerservice@elucent.com
00851674008584SmartClip - Soft Tissue Marker and Delivery System - Violet, 7.5 cm (T-Lock)844-417-1700customerservice@elucent.com
00851674008591SmartClip - Soft Tissue Marker and Delivery System - Violet, 10 cm (T-Lock)844-417-1700customerservice@elucent.com
00851674008607SmartClip Secure - Soft Tissue Marker and Delivery System - Violet (T-Lock)844-417-1700customerservice@elucent.com
10851674008352SmartClip Secure - Soft Tissue Marker and Delivery System - Pink844-417-1700customerservice@elucent.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2200061285477840K233639SmartClip Secure Soft Tissue MarkerNEU2024-12-20
2200061118849787K183400EnVisio Navigation SytemNEU2019-03-22
2200061874752718K180640SmartClip Soft Tissue MarkerNEU2018-06-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEU32024-12-20

PMN#

GUDID#

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