Marker, Colon
The Colon Marker is a gastroenterology device consisting of small, radiopaque markers that are ingested or placed in the gastrointestinal tract to assess colonic transit time through serial radiographic imaging, aiding in the evaluation of constipation and colonic motility disorders. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 876.1500 (Gastroenterology and Urology specialty).
Research product code NBG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NBG
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.