Panels › General, Plastic Surgery › Product code OMT · Class 2
Absorbable Lung Biopsy Plug
Regulation 878.4755
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in OMT
| Company | 510(k)s | Recalls |
|---|---|---|
| Angiotech | 1 | 0 |
| Selio Medical Limited | 1 | 0 |
| Surgical Specialties Mexico S DE RL DE CV | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 8, 2025 | K243722 | Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre- Selio Medical Limited, IE | OMT |
| Dec 19, 2012 | DEN090007 | BIO-SEAL LUNG BIOPSY TRACT SYSTEM Angiotech, CA | OMT |
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