Biliary Stent, Drain, And Dilator Accessories

QGE · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5012

Classification

FDA Product Code: QGE
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 876.5012
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

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