OMT · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4755
Classification
FDA Product Code
OMT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4755
Review panel
AN
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.