Karl Storz Endovision, Inc.
Country not established FDA establishment FEI 1221826
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 1
Catalogue
- 510(k) 510(k)
Company details
- FDA FEI number
- 1221826
- Address
- 91 Carpenter Hill Rd, CHARLTON, MA, 01507
FDA recalls
2016
- 29 Feb 2016 Z-1333-2016 Class II Terminated 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.
Frequently asked questions
How many devices does KARL STORZ ENDOVISION, INC. have in the registry?
The registry currently lists 1 device for KARL STORZ ENDOVISION, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list KARL STORZ ENDOVISION, INC.'s devices?
Among its 1 most recently registered device, KARL STORZ ENDOVISION, INC. has devices listed in FDA 510(k) (1 device).
What risk classes do KARL STORZ ENDOVISION, INC.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for KARL STORZ ENDOVISION, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for KARL STORZ ENDOVISION, INC.?
FDA recall records list 1 recall initiated by KARL STORZ ENDOVISION, INC., the most recent initiated on 2016-02-29. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from KARL STORZ ENDOVISION, INC. in the registry?
The most recently registered devices listed for KARL STORZ ENDOVISION, INC. include KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1).