Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012940012

FEI Number

3012940012

Entity Name

Sutter Medical Technologies USA Inc.

City/State/Country

Alpharetta, GA, US

Establishment Address

3159 Royal Drive, Suite #340, Alpharetta, GA 30022, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Sutter Medizintechnik GmbH (Owner Number: 9005453)

Owner / Operator Contact Address

Alfred-Walz-Strasse 22, Emmendingen, DE-BW 79312, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123478

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2020-02-05

Official Correspondent

Simone Peschl

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sutter Medizintechnik GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8044091	SUTTER MEDIZINTECHNIK GMBH	Emmendingen Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04
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

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
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3015506965	SMICNA PTE LTD	Singapore Central Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012940012. Last updated year: 2026. Please use registration number 3012940012 when referencing this establishment in official correspondence.