FDA product code SCB: Deflation Needle For Removal Of Intragastric Balloon
SCB is the FDA product code for deflation needle for removal of intragastric balloon. It is a Class II device, regulated under 21 CFR 876.1550 and reviewed by the Gastroenterology and Urology panel. Devices under SCB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Deflation Needle For Removal Of Intragastric Balloon |
| Device class | Class II |
| Regulation | 21 CFR 876.1550 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for SCB devices
openFDA lists no recalls for product code SCB.
Frequently asked questions
What is FDA product code SCB?
SCB is the FDA product code for deflation needle for removal of intragastric balloon. It is a Class II device, regulated under 21 CFR 876.1550 and reviewed by the Gastroenterology and Urology panel.
What device class is SCB?
Class II, regulation 21 CFR 876.1550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SCB
- Run a recall and safety report across every SCB manufacturer
- Watch product code SCB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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