SCB
- Product code
- SCB
- Device name
- Deflation Needle For Removal Of Intragastric Balloon
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1550
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
FDA classification 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.
Official FDA classification page: SCB
Classification and pathway per current FDA publications. Data from openFDA (CC0).