Clearance Summary
BIO-SEAL LUNG BIOPSY TRACT SYSTEM received FDA 510(k) clearance under submission number DEN090007, sponsored by Angiotech. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-12-19.
- Submission: DEN090007
- Applicant / Sponsor: Angiotech
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4755
- Decision date: 2012-12-19
Classification & Regulation
This clearance is catalogued under FDA product code OMT and 21 CFR 878.4755, within the General, Plastic Surgery review panel as a Class II device.