Caldera Medical Transobturator Helical Introducer, Left +4 more— 510(k) K172614
Substantially EquivalentCaldera Medical, Inc.
FDA 510(k) clearance K172614 for Caldera Medical Transobturator Helical Introducer, Left +4 more, Substantially Equivalent on 2018-05-04. Applicant: Caldera Medical, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- Caldera Medical, Inc.
- Product code
- Code PWJ
- Device class
- Class 2
- Regulation
- 21 CFR 884.4910
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Agoura Hills, CA, US
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More clearances from Caldera Medical, Inc.
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