Clearance Summary
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left received FDA 510(k) clearance under submission number K172614, sponsored by Caldera Medical, Inc.. 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 2018-05-04.
- Submission: K172614
- Applicant / Sponsor: Caldera Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4910
- Decision date: 2018-05-04
Classification & Regulation
This clearance is catalogued under FDA product code PWJ and 21 CFR 884.4910, within the Obstetrics/Gynecology review panel as a Class II device.