Clearance Summary
LI VASECTOMY received FDA 510(k) clearance under submission number K932465, sponsored by Femcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1994-03-02.
- Submission: K932465
- Applicant / Sponsor: Femcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1994-03-02
Classification & Regulation
This clearance is catalogued under FDA product code KOA and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.