Pentax Precision Instrument Corp.
United StatesFDA applicant, unverified
- Devices
- 67
What Pentax Precision Instrument Corp. makes
Pentax Precision Instrument Corp. manufactures a range of endoscopic devices, including fiber and video-based esophagoscopes, gastroscopes, sigmoidoscopes, colonoscopes, choledochoscopes, and laryngoscopes. Their portfolio also includes bronchoscopes, light sources for endoscopic procedures, and specialized upper gastrointestinal scopes. These instruments are designed for diagnostic and therapeutic procedures in gastrointestinal, respiratory, and biliary tracts.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance registry. Products are listed under the U.S. jurisdiction, adhering to applicable medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 67 devicesShowing 1-50 of 67
Frequently asked questions
How many devices does Pentax Precision Instrument Corp. have in the registry?
The registry currently lists 67 devices for Pentax Precision Instrument Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pentax Precision Instrument Corp.'s devices?
Among its 50 most recently registered devices, Pentax Precision Instrument Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Pentax Precision Instrument Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Pentax Precision Instrument Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pentax Precision Instrument Corp. in the registry?
The most recently registered devices listed for Pentax Precision Instrument Corp. include FE-34TH, FIBER ESOPHAGOSCOPE, EG-3630UR, ULTRASUND VIDEO GASTROSCOPE, FS-38X, FIBER SIGMOIDOSCOPE and KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH).