Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter— 510(k) K180302
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K180302 for Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter, Substantially Equivalent on 2018-10-24. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code MQF
- Device class
- Class 2
- Regulation
- 21 CFR 884.6110
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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More clearances from Cook Incorporated
view allData sourced from openFDA. This site is unofficial and independent of the FDA.