Clearance Summary
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 received FDA 510(k) clearance under submission number K002912, sponsored by Sterinc. 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 2001-02-21.
- Submission: K002912
- Applicant / Sponsor: Sterinc
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2001-02-21
Classification & Regulation
This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.