FCY — Bulb, Inflation, For Endoscope Class I
FDA product code FCY covers "Bulb, Inflation, For Endoscope", a Class I medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCY
- Device Class
- Class I
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.