Clearance Summary
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 received FDA 510(k) clearance under submission number K031173, sponsored by Needle Tech Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2003-07-23.
- Submission: K031173
- Applicant / Sponsor: Needle Tech Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2003-07-23
Classification & Regulation
This clearance is catalogued under FDA product code GDF and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.