510(k) K243722
- 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)
- Applicant
- Selio Medical Limited
- 510(k) number
- K243722
- Product code
- OMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-08
- Date received
- 2024-12-03
- Regulation
- 878.4755
- Classification name
- Absorbable Lung Biopsy Plug
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Colm McGarvey
- Address
- Unit 53 Guinness Enterprise Centre, Taylors Ln., Dublin 8 Dublin IE D08 R9YW D08 R9YW
FDA Registration Numbers#
- 3006950086
- 1721676
- 3011642792
- 1721504
- 3012536737
- 3033589330
- 1724474
- 3015309643
- 3015225571
- 2030624
Source Documents#
Other 510(k) Records For Product Code OMT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN090007 | BIO-SEAL LUNG BIOPSY TRACT SYSTEM | Angiotech | 2012-12-19 |