Esophageal Sheath With Distal Balloon Anchor

QGG · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1510

Classification

FDA Product Code: QGG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.1510
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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