Clearance Summary
Graft Delivery Device with Integrated Stylet received FDA 510(k) clearance under submission number K151543, sponsored by Micromedics, Inc. (D/B/A Nordson Medical). The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-07-07.
- Submission: K151543
- Applicant / Sponsor: Micromedics, Inc. (D/B/A Nordson Medical)
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2015-07-07
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.