Clearance Summary
TEFLON UTERINE SOUND received FDA 510(k) clearance under submission number K870550, sponsored by Cook Ob/Gyn. 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 1987-03-04.
- Submission: K870550
- Applicant / Sponsor: Cook Ob/Gyn
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1987-03-04
Classification & Regulation
This clearance is catalogued under FDA product code HHM and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.