Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003724334

FEI Number

3003724334

Entity Name

Olympus Winter & Ibe GmbH

City/State/Country

TELTOW Brandenburg, DE

Establishment Address

Berlin facility, Rheinstrasse 8, TELTOW Brandenburg 14513, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLYMPUS CORPORATION (Owner Number: 9067818)

Owner / Operator Contact Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160639

PMA Number

N/A

All Registered Proprietary Names

ESG-400 Electrosurgical Generator ESG-410 and Accessories WA91302W WA91307W WA91303W WA91301W PK-CF0533 WA91307C Versapoint CELON ENT SYSTEM Pressure Reducer ESG-300 MAPC Probes ESG-150 CELON ELITE ESG-200

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	2021-07-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-09
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2023-11-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-09-08
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2014-06-09
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2014-06-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

OLYMPUS CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004450998	Gyrus ACMI, Inc.	Redmond, WA, US
3007389669	Algram Group Ltd	Plymouth Devon, GB
9611174	KEYMED (Medical & Industrial Equipment) Ltd	SOUTHEND-ON-SEA Essex, GB
3010590422	QUEST MEDICAL IMAGING	Wieringerwerf Noord-Holland, NL
3031983124	ODIN MEDICAL LIMITED	London London, City of, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K182587	Olympus Winter & Ibe GmbH	Device Electrosurgical Generator ESG-150	2018-11-29
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
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 3003724334. Last updated year: 2026. Please use registration number 3003724334 when referencing this establishment in official correspondence.