Product code OMT

Device name
Absorbable Lung Biopsy Plug
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4755
Review panel
AN
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
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.
Source
FDA openFDA device classification dataset