Max Endoscopy, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Max Endoscopy, Inc. makes
Max Endoscopy, Inc. manufactures endoscopic accessories, including the SUCCESS Cecal Intubation Assist (Model 4100) for improved colonoscopy navigation and the Precision Endoscopic Infrared Coagulator (Model 5100), a reusable device for tissue coagulation. It also produces the Maxi-Guide Flexible Lightguide (Model 5100-2), a single-use attachment designed to enhance endoscopic illumination and visibility.
The company’s portfolio consists of Class II devices, all of which are listed under the FDA’s 510(k) pathway. These products are regulated under U.S. medical device laws and are intended for use within the United States.
Catalogue
Success Cecal Intubation Assist, Model: 4100 Ref K080764
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Max Endoscopy, Inc. have in the registry?
The registry currently lists 2 devices for Max Endoscopy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Max Endoscopy, Inc.'s devices?
Among its 2 most recently registered devices, Max Endoscopy, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Max Endoscopy, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Max Endoscopy, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Max Endoscopy, Inc. in the registry?
The most recently registered devices listed for Max Endoscopy, Inc. include SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 and PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2.