QTNClass II
Orally Ingested Transient Device For Constipation
Gastroenterology, Urology · 21 CFR 876.5940
An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.
MDR events34All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances3All time
Recent MDR events
34 adverse event reports on file
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00002
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00003
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00004
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00005
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00006
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00007
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00008
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00009
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00010
- VIBRANT SYSTEM CAPSULESJul 2, 2026InjuryVibrant Ltd3025305436-2026-00011
Event type breakdown
Injury25
Malfunction9
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
3 clearances for this product code