Nextern

FDA Device Registration & Listing · Maple Grove, MN, US · Registration 3031976597

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031976597
FEI Number
3031976597
Entity Name
Nextern
City/State/Country
Maple Grove, MN, US
Establishment Address
10601 Fountains Drive, Maple Grove, MN 55369, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Nextern Innovation, Inc (Owner Number: 10037078)
Owner / Operator Contact Address
10601 Fountains Drive, Maple Grove, MN 55369, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CarePath IotaSOFT Insertion System Pelvital Flyte MTI-1.5 Prodigy Thrombectomy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2026-02-26
QQH Powered Insertion System For A Cochlear Implant Electrode Array Ear, Nose, Throat Class 2 874.4450 2024-12-02
HIR Perineometer Obstetrics/Gynecology Class 2 884.1425 2024-04-09
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2022-05-10

Official Correspondent

Caroline Byrd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nextern Innovation, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3023531666 Nextern Costa Rica Ltd. Cartago, CR
3016908271 Nextern Vietnam LLC Ben Cat District Binh Duong, VN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K241362 Surmodics,Inc. Pounce XL Thrombectomy System (PTS-1011-7F135) 2024-09-11
K220887 Inari Medical Mini-ClotTriever Thrombectomy System 2022-08-04
K250421 Inari Medical, Inc. InThrill™ Thrombectomy System 2025-05-12
K192036 Inari Medical ClotTriever Thrombectomy System 2019-08-29

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3011383638 POTRERO MEDICAL, INC. Hayward, CA, US
8030124 SAVYON DIAGNOSTICS LTD. ASHDOD Southern, IL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031976597. Last updated year: 2026. Please use registration number 3031976597 when referencing this establishment in official correspondence.
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