SUTTER MEDIZINTECHNIK GMBH

FDA Device Registration & Listing · Emmendingen Baden-Wurttemberg, DE · Registration 8044091

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
8044091
FEI Number
3004857377
Entity Name
SUTTER MEDIZINTECHNIK GMBH
City/State/Country
Emmendingen Baden-Wurttemberg, DE
Establishment Address
Alfred-Walz-Strasse 22, Emmendingen Baden-Wurttemberg D-79312, DE
Establishment Type(s)
Manufacture 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
N
Expiration Date (Year)
2026
510(k) Number
K131012
PMA Number
N/A

All Registered Proprietary Names

Bipolar cable SUTTER Electrosurgical Cables Bipolar cable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRX Arthroscope Orthopedic Class 2 888.1100 2026-03-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-02-13
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1997-01-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-09-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-09-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-11-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-07
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2026-06-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-10-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-10-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-02-17
FQH Lavage, Jet General Hospital Class 2 880.5475 2024-02-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-03-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-06-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-01-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
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
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3014615697 AMNOTEC INTERNATIONAL MEDICAL GMBH Neuhausen ob Eck Baden-Wurttemberg, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044091. Last updated year: 2026. Please use registration number 8044091 when referencing this establishment in official correspondence.
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