OMT — Absorbable Lung Biopsy Plug Class II

FDA Device Classification

Classification Details

Product Code
OMT
Device Class
Class II
Regulation Number
878.4755
Submission Type
Review Panel
AN
Medical Specialty
General, Plastic Surgery
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243722selio medical limitedPre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung BiopsyApril 8, 2025
DEN090007angiotechBIO-SEAL LUNG BIOPSY TRACT SYSTEMDecember 19, 2012