Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004754983

FEI Number

3004754983

Entity Name

PLASMA SURGICAL INC.

City/State/Country

ROSWELL, GA, US

Establishment Address

1125 Northmeadow Pkwy Ste 100, ROSWELL, GA 30076, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PLASMA SURGICAL INC (Owner Number: 9066219)

Owner / Operator Contact Address

1125 Northmeadow Parkway, Suite 100, Roswell, GA 30076, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253917

PMA Number

N/A

All Registered Proprietary Names

ArION ARC

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	2026-04-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PLASMA SURGICAL 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
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

Similar Registrations

Registration Number	Establishment Name	Location
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3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
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 3004754983. Last updated year: 2026. Please use registration number 3004754983 when referencing this establishment in official correspondence.