Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

ODE · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500

Classification

FDA Product Code: ODE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.1500
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.

Market data

Cleared 510(k) submissions: 20
Registered establishments: 11

Source

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