OMT

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Absorbable Lung Biopsy Plug

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4755

Medical specialty

General, Plastic Surgery

Flags

Implant

FDA 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.

Adverse events (MAUDE)

2026: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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