Bowel Management Systems, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Bowel Management Systems, LLC makes
Bowel Management Systems, LLC manufactures indwelling fecal management systems, including both sterile and non-sterile versions designed for long-term use. These devices are intended for patients requiring continuous or intermittent fecal diversion, such as those with spinal cord injuries or other conditions affecting bowel control.
The company’s products fall under FDA Class II medical devices and are subject to 510(k) clearance requirements. The portfolio is listed in the FDA’s 510(k) database, reflecting regulatory compliance for commercial distribution in the United States.
Catalogue
Indwelling Fecal Management System-Non-Sterile Ref K023344
510(k) 510(k)Indwelling Fecal Management System Ref K012113
510(k) 510(k)
Frequently asked questions
How many devices does Bowel Management Systems, LLC have in the registry?
The registry currently lists 2 devices for Bowel Management Systems, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bowel Management Systems, LLC's devices?
Among its 2 most recently registered devices, Bowel Management Systems, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Bowel Management Systems, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bowel Management Systems, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bowel Management Systems, LLC in the registry?
The most recently registered devices listed for Bowel Management Systems, LLC include INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE and INDWELLING FECAL MANAGEMENT SYSTEM.