Bulb, Inflation, For Endoscope

FCY · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.1500

Classification

FDA Product Code: FCY
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 876.1500
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 49

Source

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