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)

510(k) number: K243722
Device name: 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 IE
Product code: OMT — Absorbable Lung Biopsy Plug
Decision date: 2025-04-08
Date received: 2024-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain

Also available from FDA: K243722.pdf

Official FDA record: K243722

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.