Optus, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Optus, Inc. makes
Optus, Inc. manufactures endoscopic instruments, including arthroscopes, mini-arthroscopes, and their accessories for joint visualization; sinus endoscopes and related tools for sinus cavity procedures; hysteroscopes and contact hysteroscopes for uterine cavity inspection; laryngoscopes for airway visualization; bronchoscopes for lung examination; cystoscopes and pediatric cystoscopes for bladder and urinary tract assessment; laparoscopes and operating laparoscopes for abdominal cavity procedures; thoracoscopes for chest cavity access; and otoscopes for ear examination.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported by 510(k) clearances. Products are listed in the FDA’s 510(k) registry. Optus, Inc. is based in the United States.
Catalogue
Optus Arthroscope & Mini-Arthroscope Accessories Ref K953913
Regimes: 510(k) Registry: 510(k)Optus Sinuscopes And Accessories Ref K944656
Regimes: 510(k) Registry: 510(k)Optus Hysteroscopes And Contact Hysteroscopes Ref K945265
Regimes: 510(k) Registry: 510(k)Optus Arthroscopes And Mini-Arthroscopes Ref K945267
Regimes: 510(k) Registry: 510(k)Optus Laryngoscopes Ref K945269
Regimes: 510(k) Registry: 510(k)Optus Bronchoscopes Ref K945268
Regimes: 510(k) Registry: 510(k)Optus Cystoscopes And Pediatric Cystoscopes Ref K945262
Regimes: 510(k) Registry: 510(k)Optus Laparoscopes And Operating Laparoscopes Ref K945266
Regimes: 510(k) Registry: 510(k)Optus Thoracoscopes Ref K945263
Regimes: 510(k) Registry: 510(k)Optus Otoscopes Ref K945264
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optus, Inc. have in the registry?
The registry currently lists 10 devices for Optus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optus, Inc.'s devices?
Among its 10 most recently registered devices, Optus, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Optus, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Optus, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optus, Inc. in the registry?
The most recently registered devices listed for Optus, Inc. include OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES, OPTUS SINUSCOPES AND ACCESSORIES, OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES and OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES.