# DEN090007: Bio-Seal Lung Biopsy Tract System

- Pathway: De Novo (Post-NSE)
- Applicant: Angiotech
- Decided: Dec 19, 2012 after 1,342 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- 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) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/DEN090007
Methodology: https://510kreport.com/methodology