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) K243722

Substantially Equivalent

Selio Medical Limited

FDA 510(k) clearance K243722 for 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), Substantially Equivalent on 2025-04-08. Applicant: Selio Medical Limited.

Clearance details

Applicant: Selio Medical Limited
Product code: Code OMT
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 ↗

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