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— 510(k) K172614
Substantially EquivalentCaldera Medical, Inc.
FDA 510(k) clearance K172614 for 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, Substantially Equivalent on 2018-05-04. Applicant: Caldera Medical, Inc..
Clearance details
- Applicant
- Caldera Medical, Inc.
- Product code
- Code PWJ
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Agoura Hills, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.