FDA product code OKO

Negative Pressure Wound Therapy Non-Powered Suction Apparatus

General, Plastic Surgery·Class 2·21 CFR 878.4683
US regulatory classifications
US Product Code (FDA)
OKO
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4683
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.

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About this record

Negative Pressure Wound Therapy Non-Powered Suction Apparatus is a medical device type in the General, Plastic Surgery 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.