Clearance Summary
7-510-25 HYSTEROMED TUBING KIT received FDA 510(k) clearance under submission number K931606, sponsored by Nortech. 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 1994-01-24.
- Submission: K931606
- Applicant / Sponsor: Nortech
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1700
- Decision date: 1994-01-24
Classification & Regulation
This clearance is catalogued under FDA product code HIG and 21 CFR 884.1700, within the Obstetrics/Gynecology review panel as a Class II device.