Data / Medical devices / United States / Karl Storz Endovision, Inc.

Karl Storz Endovision, Inc.: FDA-registered device maker in Charlton, MA, United States, 1 510(k) clearance

Name: Karl Storz Endovision, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Karl Storz Endovision, Inc. is registered with the FDA (registration 1221826) in Charlton, MA, United States. It lists 31 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1221826
Address: 91 Carpenter Hill Rd, Charlton, MA, United States, 01507
Owner or operator: KARL STORZ SE & CO KG (8010119)
Roles: Contract manufacturer, Manufacturer
First device listed: August 10, 1999
Registered through: 2027
Brand names listed: 11274AB Flex Pediatric BRONCHOSCOPE, 11274AC Flex. CHOLEDOCHOSCOPE, 26025UC HAMOU Elctrnc HYSTEROFLATOR, 300W Light Source, Non-flash, 495N Series Fibr Optic Light Cables, 7.5 Fr. Flexible CHOLEDOSCHOSCOPE, CMOS Video Rhino Laryngoscope, CMOS Video-Rhino-Laryngoscope System and more

Devices it lists

Device	Product code	Class	Role	Source
Angioscope	LYK	2	Contract manufacturer	accessdata.fda.gov
Arthroscope	HRX	2	Contract manufacturer	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Contract manufacturer	accessdata.fda.gov
Camera, Television, Endoscopic, Without Audio	FWF	1	Contract manufacturer	accessdata.fda.gov
Choledochoscope And Accessories, Flexible/Rigid	FBN	2	Contract manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Contract manufacturer	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Contract manufacturer	accessdata.fda.gov
Cystourethroscope	FBO	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Endoscope, Neurological	GWG	2	Contract manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Contract manufacturer	accessdata.fda.gov
Esophagoscope (Flexible Or Rigid)	EOX	2	Contract manufacturer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Contract manufacturer	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Contract manufacturer	accessdata.fda.gov
Image, Illumination, Fiberoptic, For Endoscope	FFS	2	Contract manufacturer	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Contract manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer	accessdata.fda.gov
Kit, Nephroscope	FGA	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Contract manufacturer	accessdata.fda.gov
Laryngoscope, Non-Rigid	CAL	1	Contract manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Contract manufacturer	accessdata.fda.gov
Light Source System, Diagnostic Endoscopic	OAY	3	Contract manufacturer	accessdata.fda.gov
Light Source, Endoscope, Xenon Arc	GCT	2	Contract manufacturer	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Contract manufacturer	accessdata.fda.gov
Light Source, Photographic, Fiberoptic	FCR	2	Contract manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Contract manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Contract manufacturer	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Contract manufacturer	accessdata.fda.gov
Transilluminator, Fiber Optic	MQW	1	Contract manufacturer	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 6, 2025	K243550	KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)	FGB	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 29, 2016	72921	Class II	Terminated	ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL	Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel.	accessdata.fda.gov

Compare with other makers

Updated June 6, 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.