OMT · Class II · 21 CFR 878.4755

FDA Product Code OMT: Absorbable Lung Biopsy Plug

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.

Leading manufacturers include Selio Medical Limited.

2
Total
1
Cleared
734d
Avg days
2012
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 126d recently vs 1342d historically

FDA 510(k) Cleared Absorbable Lung Biopsy Plug Devices (Product Code OMT)

2 devices
1–2 of 2
Cleared Apr 08, 2025
Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001)
K243722
Selio Medical Limited
Anesthesiology · 126d

About Product Code OMT - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code OMT since 2012, with 1 receiving FDA clearance (average review time: 734 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under OMT have taken an average of 126 days to reach a decision - down from 1342 days historically, suggesting improved FDA processing for this classification.

OMT devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →