FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Advincula Delineator Uterine Manipulator
K Number: K180429
·
Decision Mar 14, 2018
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
17
Applicant Total
41
Review Days
26
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Basic Information
- Device Name
- Advincula Delineator Uterine Manipulator
- K Number
- K180429
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.1640
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CooperSurgical, Inc.
- Date Received
- February 16, 2018
- Decision Date
- March 14, 2018
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEW), ordered by most recent decision date.
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
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Advincula Delineator Uterine Manipulator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Transvaginal Access Platform
FDA 510(k)
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ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
FDA 510(k)
FDA Class 2
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GelPOINT Transvaginal Access Platform
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CooperSurgical Advincula Delineator Uterine Manipulator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by CooperSurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243799 | Fetal Pillow | Aug 29, 2025 | Substantially Equivalent |
| K250438 | CooperSurgical Milex® Pessaries | Apr 11, 2025 | Substantially Equivalent |
| K223064 | ALLY II Uterine Positioning System (UPS) | Oct 28, 2022 | Substantially Equivalent |
| K201086 | Advincula Delineator Uterine Manipulator | May 21, 2020 | Substantially Equivalent |
| K200038 | Endosee System | Feb 5, 2020 | Substantially Equivalent |
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | Jan 14, 2020 | Substantially Equivalent |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | Jun 12, 2019 | Substantially Equivalent |
| K190639 | Endosee System | May 15, 2019 | Substantially Equivalent |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | May 10, 2019 | Substantially Equivalent |
| K183020 | Endosee System | Jan 31, 2019 | Substantially Equivalent |