Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

QFQ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5982

Classification

FDA Product Code: QFQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5982
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 5

Source

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