Clearance Summary
AED BIPOLAR FORCEPS, MODEL 13-1646 received FDA 510(k) clearance under submission number K081553, sponsored by National Advanced Endoscopy Devices, 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 2008-09-29.
- Submission: K081553
- Applicant / Sponsor: National Advanced Endoscopy Devices, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2008-09-29
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.