FDA Product Code
FDA Product Code OMT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4755
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243722 | 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) | Selio Medical Limited | 2025-04-08 | Traditional | PDF ↗ |
| DEN090007 | BIO-SEAL LUNG BIOPSY TRACT SYSTEM | Angiotech | 2012-12-19 | Post-NSE | — |
Product code OMT · Class II · General, Plastic Surgery. Data: openFDA.