# K243722: Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)

- Pathway: 510(k) (Traditional)
- Applicant: Selio Medical Limited
- Decided: Apr 8, 2025 after 126 days
- Product code: OMT (Absorbable Lung Biopsy Plug)
- Device class: 2
- Regulation: 21 CFR 878.4755
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN090007 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN090007: Bio-Seal Lung Biopsy Tract System, Angiotech (2012) Summary page 6.

## Indications for use
The Pre-B. Seal Lung Biopsy Plug System is indicated for sealing pleural punctures to reduce the risk of pneumothoraces (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a biopsy needle entry site for visualization during surgical resection. The Pre-B. Seal Lung Biopsy Plug System is indicated for use in adult patients (22 years of age and older).

Source page: https://510kreport.com/device/K243722
Methodology: https://510kreport.com/methodology