Clearance Summary
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 received FDA 510(k) clearance under submission number K001555, sponsored by Sims Portex , Ltd.. 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 2000-08-02.
- Submission: K001555
- Applicant / Sponsor: Sims Portex , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 2000-08-02
Classification & Regulation
This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.