OMT

Absorbable Lung Biopsy Plug

Product code

OMT

Device name

Absorbable Lung Biopsy Plug

Device class

Class 2

21 CFR

21 CFR 878.4755

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-08.

1 summaries are archived here for direct download.