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FDA PRODUCT CODE · CLASS II

ORC — Air Filter Portable Apparatus

The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.5070
MEDICAL SPECIALTY
General, Plastic Surgery
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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