Kuro Medical

FDA Device Registration & Listing · Eden Prairie, MN, US · Registration 3017496797

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
3017496797
FEI Number
3017496797
Entity Name
Kuro Medical
City/State/Country
Eden Prairie, MN, US
Establishment Address
7625 Golden Triangle Dr Ste G, Eden Prairie, MN 55344, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
One Life Sciences, Inc. (Owner Number: 10078335)
Owner / Operator Contact Address
7625 Golden Triangle Dr, Ste G, Eden Prairie, MN 55344, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ATMO Gas Capsule System AMPA One System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NYV Gastrointestinal Motility System, Capsule Gastroenterology, Urology Class 2 876.1725 2025-07-01
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2026-03-31
MIB Elastomer, Silicone Block Ear, Nose, Throat Class 2 874.3620 2025-09-03
KPM Shunt, Peritoneal Gastroenterology, Urology Class 2 876.5955 2025-04-16
GBS Catheter, Ventricular, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2025-04-16

Official Correspondent

Matt Kyle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

One Life Sciences, Inc.
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
K243700 Mag & More GmbH Apollo TMS Therapy System 2025-09-04
K231926 Neuronetics, Inc. NeuroStar Advanced Therapy System (All previously cleared models) 2024-03-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0019-2011 Atrium Medical Corporation 1
HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011 Atrium Medical Corporation 1
HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132

Similar Registrations

Registration Number Establishment Name Location
3016544248 ANX ROBOTICA CORP. Plano, TX, US
3018094310 Medtronic Engineering and Innovation Center (MEIC) Hyderabad Telangana, IN
3027568582 ATMO BIOSCIENCES LTD Box Hill Victoria, AU
9710107 GIVEN IMAGING LTD. Yoqneam Northern, IL
3018708317 MAGNUS MEDICAL INC. Burlingame, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017496797. Last updated year: 2026. Please use registration number 3017496797 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.