510(k) K243722
K243722 is an FDA 510(k) premarket notification submitted by Selio Medical Limited for the device "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)". The FDA issued a decision of Substantially Equivalent on April 8, 2025. The device falls under product code OMT (Absorbable Lung Biopsy Plug), a Class II device regulated under 21 CFR 878.4755.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2025
- Date Received
- December 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Lung Biopsy Plug
- Device Class
- Class II
- Regulation Number
- 878.4755
- Review Panel
- AN
- Submission Type
A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.