Clearance Summary
ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER received FDA 510(k) clearance under submission number K881220, sponsored by Laboratoire Ccd C/O Washington Regulatory Services. 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 1988-06-14.
- Submission: K881220
- Applicant / Sponsor: Laboratoire Ccd C/O Washington Regulatory Services
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1100
- Decision date: 1988-06-14
Classification & Regulation
This clearance is catalogued under FDA product code HFE and 21 CFR 884.1100, within the Obstetrics/Gynecology review panel as a Class II device.