Endooptiks, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Endooptiks, Inc. makes
Endooptiks, Inc. manufactures urological catheters for endoscopic procedures, including the SESSR model, as well as laser systems and accessories for medical applications. Their portfolio includes microprobe lasers, endoprobes, and a combined laser-endoscopy system (Model E2). The company also produces a transtympanic endoscope for otological examinations.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are based in the United States and are intended for use in endoscopic and laser-assisted medical procedures.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Micropobe Series Of Lasers And Accessories Ref K003151
Regimes: 510(k) Registry: 510(k)Endoprobes Ref K922917
Regimes: 510(k) Registry: 510(k)Microprobe Laser And Endoscopy System, Model E2 Ref K042918
Regimes: 510(k) Registry: 510(k)Transtympanic Endoscope Ref K945081
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Endooptiks, Inc. have in the registry?
The registry currently lists 5 devices for Endooptiks, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Endooptiks, Inc.'s devices?
Among its 5 most recently registered devices, Endooptiks, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Endooptiks, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Endooptiks, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Endooptiks, Inc. in the registry?
The most recently registered devices listed for Endooptiks, Inc. include ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR, MICROPOBE SERIES OF LASERS AND ACCESSORIES, ENDOPROBES and MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2.