Orally Ingested Transient Device For Constipation
The Orally Ingested Transient Device for Constipation is an electrically active swallowable capsule that naturally passes through the gastrointestinal tract, stimulating colonic motility to treat constipation without remaining in the body permanently. It represents a novel approach to managing chronic constipation using an ingestible electronic device. Classified as FDA Class 2 under regulation 876.5940, it requires 510(k) clearance in the Gastroenterology and Urology specialty. The device is not flagged as an implant and is not life-sustaining.
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Basic Information
- Product Code
- QTN
- Device Class
- FDA class 2
- Regulation Number
- 876.5940
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.