Orally Ingested Transient Device For Constipation

QTN · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5940

Classification

FDA Product Code: QTN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5940
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown