Byrne Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Byrne Medical, Inc. makes
Byrne Medical produces endoscopic accessories and insufflation devices, including irrigation pumps (such as the EGP-100 and EndoGator Advantage), CO₂ insufflators (EndoGater Advantage), and biopsy valves (Defendo for Olympus, Fujinon, and Pentax endoscopes). The portfolio also covers disposable valves (air/water and suction), irrigation tubing, and hybrid irrigation solutions designed for gastrointestinal procedures. Additional offerings include a smart cap system (EndoSmartCap) and a hand pump with flexible probe (ErbeLift) for endoscopic applications.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) clearance pathway. The company’s products are registered with the FDA’s 510(k) database. Byrne Medical is headquartered in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Byrne Medical, Inc. have in the registry?
The registry currently lists 12 devices for Byrne Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Byrne Medical, Inc.'s devices?
Among its 12 most recently registered devices, Byrne Medical, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Byrne Medical, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Byrne Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Byrne Medical, Inc. in the registry?
The most recently registered devices listed for Byrne Medical, Inc. include ENDO GATOR SYSTEM, ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100, DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) and DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305.