Olympus Medical Systems Copr.
Country not established
- Devices
- 1
What Olympus Medical Systems Copr. makes
Olympus Medical Systems Corp. manufactures single-use preloaded sphincterotomes, specifically distal wire-guided models designed for endoscopic procedures. These devices are intended for biliary or pancreatic duct interventions to facilitate controlled cutting of strictures or stones during procedures like ERCP (endoscopic retrograde cholangiopancreatography).
The company’s products fall under FDA Class II regulation and are listed via the 510(k) pathway. These devices are registered in the U.S. under the FDA’s regulatory framework. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Olympus Medical Systems Copr. have in the registry?
The registry currently lists 1 device for Olympus Medical Systems Copr.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Olympus Medical Systems Copr.'s devices?
Among its 1 most recently registered device, Olympus Medical Systems Copr. has devices listed in FDA 510(k) (1 device).
What risk classes do Olympus Medical Systems Copr.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Olympus Medical Systems Copr.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Olympus Medical Systems Copr. in the registry?
The most recently registered devices listed for Olympus Medical Systems Copr. include SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP.