Clearance Summary
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) received FDA 510(k) clearance under submission number K243722, sponsored by Selio Medical Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-04-08.
- Submission: K243722
- Applicant / Sponsor: Selio Medical Limited
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4755
- Decision date: 2025-04-08
Classification & Regulation
This clearance is catalogued under FDA product code OMT and 21 CFR 878.4755, within the General, Plastic Surgery review panel as a Class II device.