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)
FDA 510(k) clearance K243722 · decided 2025-04-08
Clearance details
- K-number
- K243722
- Device name
- 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)
- Applicant
- Selio Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2024-12-03
- Decision date
- 2025-04-08
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- OMT
- Device class
- 2
- Regulation number
- 878.4755
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dublin, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIO-SEAL LUNG BIOPSY TRACT SYSTEM (DEN090007) | Angiotech | 2012-12-19 |
Recalls involving this device
No recalls on record reference this clearance.