Clearance Summary
LAPAROSTAT(TM) received FDA 510(k) clearance under submission number K913300, sponsored by Cook Ob/Gyn. 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 1992-04-02.
- Submission: K913300
- Applicant / Sponsor: Cook Ob/Gyn
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1992-04-02
Classification & Regulation
This clearance is catalogued under FDA product code HAM and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.