Bioenterics Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Bioenterics Corp. makes
Bioenterics Corp. manufactures endoscopic illumination tools, including the Endolumina Illuminating Bougie and Endolumina II Transillumination System with detachable tips in sizes 40FR, 50FR, and 56FR. The company also produces gastric suction and drainage catheters designed for medical procedures.
These devices are classified under FDA categories Class I and Class II, with regulatory clearance supported by 510(k) submissions. The company is based in the United States.
Catalogue
Bioenterics Endolumina Illuminating Bougie Ref K934084
Regimes: 510(k) Registry: 510(k)Gastric Suction And Drainage Catheter Ref K002838
Regimes: 510(k) Registry: 510(k)Bioentrics Endolumina Illuminated Bougie Ref K924753
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioenterics Corp. have in the registry?
The registry currently lists 4 devices for Bioenterics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioenterics Corp.'s devices?
Among its 4 most recently registered devices, Bioenterics Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Bioenterics Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bioenterics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioenterics Corp. in the registry?
The most recently registered devices listed for Bioenterics Corp. include BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE, GASTRIC SUCTION AND DRAINAGE CATHETER, BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE and ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA.