Gabriel Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Gabriel Medical, Inc. makes
Gabriel Medical, Inc. manufactures ureteral illumination systems, including the Gabriel Ureteral Illuminator System and its second-generation variant, as well as bougie and esophageal imaging kits under the Infra Vision brand. The company also produces thermal recording devices for clinical use, such as the Gabriel Medical CLS Thermal Recorder. Additionally, it offers an imaging system designed for endoscopic procedures.
The company’s products are classified under FDA regulations as Class I and Class II devices, with several authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s regulatory database, and the manufacturer is based in the United States.
Catalogue
Gabriel Ureteral Illuminator System Ref K940019
Regimes: 510(k) Registry: 510(k)Gabriel Ureteral Illuminator System Ii Ref K945088
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Gabriel Medical Cls Thermal Recorder Ref K901385
Regimes: 510(k) Registry: 510(k)Infra Vision Imaging System Ref K945297
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gabriel Medical, Inc. have in the registry?
The registry currently lists 5 devices for Gabriel Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gabriel Medical, Inc.'s devices?
Among its 5 most recently registered devices, Gabriel Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Gabriel Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Gabriel Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gabriel Medical, Inc. in the registry?
The most recently registered devices listed for Gabriel Medical, Inc. include GABRIEL URETERAL ILLUMINATOR SYSTEM, GABRIEL URETERAL ILLUMINATOR SYSTEM II, INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT and GABRIEL MEDICAL CLS THERMAL RECORDER.