Clearance Summary
EURO-MED ENDO-CURETTE received FDA 510(k) clearance under submission number K882606, sponsored by Buckman Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1988-07-25.
- Submission: K882606
- Applicant / Sponsor: Buckman Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1050
- Decision date: 1988-07-25
Classification & Regulation
This clearance is catalogued under FDA product code PCF and 21 CFR 884.1050, within the Obstetrics/Gynecology review panel as a Class II device.