Clearance Summary
ESTECH COBRA BIPOLSR II received FDA 510(k) clearance under submission number K100224, sponsored by Endoscopic Technologies, Inc. D/B/A Estech. 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 2010-04-07.
- Submission: K100224
- Applicant / Sponsor: Endoscopic Technologies, Inc. D/B/A Estech
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2010-04-07
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.