Clearance Summary
STRYKER BIPOLAR FORCEPS received FDA 510(k) clearance under submission number K093108, sponsored by Stryker Leibinger GmbH & Co KG. 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 2010-06-22.
- Submission: K093108
- Applicant / Sponsor: Stryker Leibinger GmbH & Co KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2010-06-22
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.