OMT — Absorbable Lung Biopsy Plug Class II
FDA product code OMT covers "Absorbable Lung Biopsy Plug", a Class II medical device regulated under 21 CFR 878.4755. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OMT
- Device Class
- Class II
- Regulation Number
- 878.4755
- Submission Type
- Review Panel
- AN
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
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.