American Endoscopy, Inc.
United StatesFDA applicant, unverified
- Devices
- 19
What American Endoscopy, Inc. makes
American Endoscopy, Inc. manufactures endoscopic retrieval forceps, lavaging catheters, and pigtail stents for biliary and pancreatic interventions, along with sterile cytology brushes for tissue sampling. Their portfolio includes retrieval balloons, papillotomes, and E.R.C.P. cannulas for procedural access and stone removal, as well as injection aspirating needles for fluid management. The company also produces an automatic endoscope for procedural support and a Proxima 1 pH monitor for gastrointestinal diagnostics.
The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance in the United States.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does American Endoscopy, Inc. have in the registry?
The registry currently lists 19 devices for American Endoscopy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Endoscopy, Inc.'s devices?
Among its 19 most recently registered devices, American Endoscopy, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do American Endoscopy, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for American Endoscopy, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Endoscopy, Inc. in the registry?
The most recently registered devices listed for American Endoscopy, Inc. include RETRIEVAL FORCEPS, PERCUTANEOUS ENDOSCOPIC GASTROSCOPY, PROXIMA 1 PH MONITOR and PAPILLOTOMES.