FDA product code SCB

Deflation Needle For Removal Of Intragastric Balloon

Gastroenterology, Urology·Class 2·21 CFR 876.1550
US regulatory classifications
US Product Code (FDA)
SCB
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.1550
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Deflation Needle For Removal Of Intragastric Balloon is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.