K243722 is an FDA 510(k) clearance for the Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001). This device is classified as a Absorbable Lung Biopsy Plug (Class II - Special Controls, product code OMT).
Submitted by Selio Medical Limited (Dublin, IE). The FDA issued a Cleared decision on April 8, 2025, 126 days after receiving the submission on December 3, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.4755. 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..
| 510(k) Number | K243722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2024 |
| Decision Date | April 08, 2025 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | OMT - Absorbable Lung Biopsy Plug |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4755 |
| Definition | 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. |