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FDA PRODUCT CODE · CLASS III

OYF — Aspiration Therapy System

Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
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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