SCB — Deflation Needle For Removal Of Intragastric Balloon Class II
FDA product code SCB covers "Deflation Needle For Removal Of Intragastric Balloon", a Class II medical device regulated under 21 CFR 876.1550. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- SCB
- Device Class
- Class II
- Regulation Number
- 876.1550
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.