FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Wallace Dual Lumen Oocyte Recovery System
K Number: K191291
·
Decision Jun 12, 2019
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
41
Review Days
29
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Basic Information
- Device Name
- Wallace Dual Lumen Oocyte Recovery System
- K Number
- K191291
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.6100
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CooperSurgical, Inc.
- Date Received
- May 14, 2019
- Decision Date
- June 12, 2019
- Product Code
- MQE
- 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 |
|---|---|---|---|
| MQE | Needle, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQE), ordered by most recent decision date.
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Wallace Dual Lumen Oocyte Recovery System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Single Lumen Ovum Aspiration Needles
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 |
| 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 |
| K180429 | Advincula Delineator Uterine Manipulator | Mar 14, 2018 | Substantially Equivalent |