Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001) +2 more— 510(k) K243722

Name: FDA 510(k) clearance K243722
Creator: U.S. Food and Drug Administration
Published: 2025-04-08

Substantially Equivalent

Selio Medical Limited

FDA 510(k) clearance K243722 for Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001) +2 more, Substantially Equivalent on 2025-04-08. Applicant: Selio Medical Limited. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Selio Medical Limited
Product code: Product code OMT
Device class: Class 2
Regulation: 21 CFR 878.4755
Advisory panel: General, Plastic Surgery
Date received: 2024-12-03
Decision date: 2025-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMT

view all

DEN090007 — BIO-SEAL LUNG BIOPSY TRACT SYSTEM2012-12-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.