Deflation Needle For Removal Of Intragastric Balloon

SCB · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1550

Classification

FDA Product Code: SCB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.1550
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Deflation needle is a prescription use device intended to puncture and drain fluid from an intragastric balloon so that the empty balloon may be removed endoscopically.

Market data

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

Source

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