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FDA PRODUCT CODE · CLASS II

OBK — Port, Protector/Cushion

Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5965
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— 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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