Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012266672

FEI Number

3012266672

Entity Name

Resolution Medical

City/State/Country

Minneapolis, MN, US

Establishment Address

42 Northern Stacks Drive, Suite 200, Minneapolis, MN 55421, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Resolution Medical, LLC (Owner Number: 10050670)

Owner / Operator Contact Address

42 Northern Stacks Drive, Suite 200, Minneapolis, MN 55421, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StimRouter Neuromodulation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2025-12-22
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2022-08-05
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2022-08-05
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2024-01-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-12-21
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2023-03-22
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2024-01-17
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2015-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Resolution Medical, LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3015425075	NALU MEDICAL	Carlsbad, CA, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3009595577	BIOVENTUS LLC	Durham, NC, US
3004209178	MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS	Juncos, PR, US
3027669735	Bioventus LLC	Cordova, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012266672. Last updated year: 2026. Please use registration number 3012266672 when referencing this establishment in official correspondence.