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FDA PRODUCT CODE · CLASS II

SCB — Deflation Needle For Removal Of Intragastric Balloon

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1550
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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