Gulf Medical Fiberoptics
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Gulf Medical Fiberoptics makes
Gulf Medical Fiberoptics manufactures surgical headlights and endoscopic fiberoptic cables, designed for use in minimally invasive procedures and surgical applications requiring precise illumination or flexible imaging tools.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Surgical Headlight Ref K061690
Regimes: 510(k) Registry: 510(k)Endoscopic Fiberoptic Cable Ref K021931
Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID
FDA recalls
FDA recall records list 1 recall initiated by Gulf Medical Fiberoptics, initiated on 2011-05-13. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 13 May 2011 Z-0831-2012 Unclassified (pre-2012) Terminated Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated.
Full distribution text
- 13 May 2011 Z-0831-2012 Unclassified (pre-2012) Terminated Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated.
Frequently asked questions
How many devices does Gulf Medical Fiberoptics have in the registry?
The registry currently lists 2 devices for Gulf Medical Fiberoptics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gulf Medical Fiberoptics's devices?
Among its 2 most recently registered devices, Gulf Medical Fiberoptics has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Gulf Medical Fiberoptics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gulf Medical Fiberoptics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Gulf Medical Fiberoptics?
FDA recall records list 1 recall initiated by Gulf Medical Fiberoptics, the most recent initiated on 13 May 2011. 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 Gulf Medical Fiberoptics in the registry?
The most recently registered devices listed for Gulf Medical Fiberoptics include SURGICAL HEADLIGHT and ENDOSCOPIC FIBEROPTIC CABLE.