FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ally Uterine Positioning System
K Number: K153092
·
Decision Dec 21, 2015
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
41
Review Days
56
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Basic Information
- Device Name
- Ally Uterine Positioning System
- K Number
- K153092
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CooperSurgical, Inc.
- Date Received
- October 26, 2015
- Decision Date
- December 21, 2015
- Product Code
- LKF
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
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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 |