FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CooperSurgical Advincula Delineator Uterine Manipulator
K Number: K143650
·
Decision Jul 21, 2015
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
16
Applicant Total
1
Review Days
210
Basic Information
- Device Name
- CooperSurgical Advincula Delineator Uterine Manipulator
- K Number
- K143650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1640
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cooper Surgical Inc.
- Date Received
- December 23, 2014
- Decision Date
- July 21, 2015
- Product Code
- HEW
- 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 |
|---|---|---|---|
| HEW | Culdoscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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