Data / Medical devices / Cystourethroscope

Cystourethroscope (FBO): 16 FDA-registered makers in 5 countries

Name: FDA-registered makers of Cystourethroscope
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

16 establishments in 5 countries are registered with the FDA to make Cystourethroscope (product code FBO, Class 2, 21 CFR 876.1500). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on May 2, 2025, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: FBO
Device class: 2
Regulation: 876.1500
Medical specialty: Gastroenterology, Urology

Makers by country

Country	Makers
Germany	7
United States	5
Japan	2
Estonia	1
Switzerland	1

Makers of Cystourethroscope

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Karl Storz Endoscopy-America, Inc.	Auburn, MA, United States	Contract manufacturer, Repackager or relabeler	7	May 2, 2025	0	api.fda.gov
Karl Storz Se & Co KG	TUTTLINGEN Baden-Wurttemberg, Germany	Specification developer	7	May 2, 2025	0	api.fda.gov
Richard Wolf GMBH	KNITTLINGEN Baden-Wurttemberg, Germany	Manufacturer	2	August 10, 2001	0	api.fda.gov
Aizu Olympus Co., Ltd.	AIZUWAKAMATSU-SHI Fukushima, Japan	Manufacturer	1	January 3, 1985	1	api.fda.gov
Gyrus ACMI, Inc.	Brooklyn Park, MN, United States	Complaint file establishment, Specification developer	1	July 21, 1995	0	api.fda.gov
Olympus Medical Systems Corp.	HACHIOJI-SHI Tokyo, Japan	Specification developer	1	January 3, 1985	0	api.fda.gov
Alleima Karlsruhe GmbH	Karlsruhe Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Karl Storz Endovision, Inc.	Charlton, MA, United States	Contract manufacturer	0		0	api.fda.gov
Karl Storz Se & Co. KG	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Karl Storz Se & Co. KG	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Karl Storz Se & Co. KG	NEUHAUSEN OBECK Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Karl Storz Video Endoscopy Estonia Oue	Laagri Harjumaa, Estonia	Contract manufacturer	0		0	api.fda.gov
Nissha Medical Technologies (Ohio), Inc.	Norwalk, OH, United States	Contract manufacturer	0		0	api.fda.gov
Richard Wolf Medical Instruments Corp.	Vernon Hills, IL, United States	Contract manufacturer	0		0	api.fda.gov
Storz Endoskop Produktions GMBH	Schaffhausen, Switzerland	Contract manufacturer	0		0	api.fda.gov
medi-G GMBH	Messkirch Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov

Updated May 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.