Clearance Summary
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER received FDA 510(k) clearance under submission number K014248, sponsored by Urogyn , 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 2002-03-21.
- Submission: K014248
- Applicant / Sponsor: Urogyn , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2002-03-21
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.