Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014653199

FEI Number

3014653199

Entity Name

ELUCENT MEDICAL INC.

City/State/Country

Eden Prairie, MN, US

Establishment Address

6509 Flying Cloud Drive, Suite 160, Eden Prairie, MN 55344, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Elucent Medical Inc. (Owner Number: 10057977)

Owner / Operator Contact Address

6509 Flying Cloud Drive, Suite 160, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233639

PMA Number

N/A

All Registered Proprietary Names

SmartClip Secure Soft Tissue Marker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-05-07

Official Correspondent

Judson Guericke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elucent Medical Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014653199. Last updated year: 2026. Please use registration number 3014653199 when referencing this establishment in official correspondence.