FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
K Number: K140761
·
Decision Apr 21, 2014
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
12
Applicant Total
12
Review Days
26
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Basic Information
- Device Name
- KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
- K Number
- K140761
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.1300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carefusion 2200, Inc.
- Date Received
- March 26, 2014
- Decision Date
- April 21, 2014
- Product Code
- HES
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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