Clearance Summary
ENTACT SEPTAL STAPLER, MODEL 610-00100 received FDA 510(k) clearance under submission number K082750, sponsored by Entrigue Surgical, 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 2009-01-06.
- Submission: K082750
- Applicant / Sponsor: Entrigue Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2009-01-06
Classification & Regulation
This clearance is catalogued under FDA product code OLL and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.