Clearance Summary
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX received FDA 510(k) clearance under submission number K033177, sponsored by Gunter Bissinger Medizintechnik GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2004-03-11.
- Submission: K033177
- Applicant / Sponsor: Gunter Bissinger Medizintechnik GmbH
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2004-03-11
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.