Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615001

FEI Number

3003922255

Entity Name

INNOVIEW GMBH

City/State/Country

Eichstetten Baden-Wurttemberg, DE

Establishment Address

Bruckmatten 35, Eichstetten Baden-Wurttemberg D-79356, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INNOVIEW GMBH (Owner Number: 9026517)

Owner / Operator Contact Address

Bruckmatten 35, Eichstetten, DE-NOTA D-79356, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BAHO AUTOCALAVABLE CYSTOSCOPE BAHO ARTHROSCOPE RUDOLF INNOVIEW AUTOCLAVABLE SEMI-R BAHO AUTOCLAVABLE LAPAROSCOPE BAHO OTOSCOPE Innoview Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-01
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-11-05
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-05
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-05
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	1997-06-03
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2007-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

GERALD GOIGITZER Business: INNOVATIVE ENDOSCOPY COMPONENTS, LLC. Email: gerald@endoscopy.md Phone: (954) 2178780

Related Public Records

Same Entity

INNOVIEW GMBH

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
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
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Similar Registrations

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9614434	STORZ ENDOSKOP PRODUKTIONS GMBH	SCHAFFHAUSEN, CH
3035710892	Guangdong MacroLux Medical Technology Co., Ltd.	Dongguan Guangdong, CN
3008386005	IAN JAMIESON PTY LTD	Fyshwick Australian Capital Territory, AU
3008837339	STRYKER EMEA Supply Chain Services	Venlo Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615001. Last updated year: 2026. Please use registration number 9615001 when referencing this establishment in official correspondence.