Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008849319

FEI Number

3008849319

Entity Name

US MEDICAL INNOVATIONS, LLC

City/State/Country

Takoma Park, MD, US

Establishment Address

6930 Carroll Ave Ste 1000, Takoma Park, MD 20912, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

US Medical Innovations, LLC (Owner Number: 10034925)

Owner / Operator Contact Address

6930 Carroll Avenue, Suite 1000, Takoma Park, MD 20912, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052035

PMA Number

N/A

All Registered Proprietary Names

Canady Helios Cold Plasma XL-1000CP Ablation System Canady Hybrid Plasma Scalpel Canady Viera Hybrid Plasma Scapel Canady Plasma Electrosurgical Unit & Accessories Canady Plasma Electrosurgical Unit Series SS601MCA, SS-200E/Canady Plasma Coagulator Argon 2 and Argon 4 with acccess. Canady Plasma Electrosurgical Unit Series SS601MCA, SS-200E/Canady Plasm Coagulator Argon 2 and Argon 4 with accessories Canady Plasma Electrosurgical Unit & Accessories Canady Helios Cold Plasma XL-1000CP Ablation System Canady Hybrid Plasma Scalpel Canady Viera Hybrid Plasma Scalpel Canady Argon Plasma Probes Canady Plasma TBS Probe Canady Plasma Probes for Flexible Endoscopy Canady Plasma GIT Probe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-07-23
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2025-07-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-04-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-04-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-06
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2024-05-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-01-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-01-17

Official Correspondent

Katherine Korinko

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

US Medical Innovations, 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008849319. Last updated year: 2026. Please use registration number 3008849319 when referencing this establishment in official correspondence.