FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
K Number: K172321
·
Decision Dec 21, 2017
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
50
Applicant Total
118
Review Days
142
Basic Information
- Device Name
- Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
- K Number
- K172321
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.6110
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- August 1, 2017
- Decision Date
- December 21, 2017
- Product Code
- MQF
- 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 |
|---|---|---|---|
| MQF | Catheter, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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