Clearance Summary
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE received FDA 510(k) clearance under submission number K001270, sponsored by Gyrus Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2000-04-28.
- Submission: K001270
- Applicant / Sponsor: Gyrus Medical , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-04-28
Classification & Regulation
This clearance is catalogued under FDA product code FJL and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.