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Absorbable Lung Biopsy Plug

FDA product code OMT · 1 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4755
Review panel
AN
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-04-08 – 2025-04-08

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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