FDA product code OMT

Absorbable Lung Biopsy Plug

General, Plastic Surgery·Class 2·21 CFR 878.4755·Implantable
US regulatory classifications
US Product Code (FDA)
OMT
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4755
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.

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About this record

Absorbable Lung Biopsy Plug 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. This device type includes implantable products.

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.