FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
K Number: K173731
·
Decision Mar 2, 2018
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
41
Review Days
86
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Basic Information
- Device Name
- SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
- K Number
- K173731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CooperSurgical, Inc.
- Date Received
- December 6, 2017
- Decision Date
- March 2, 2018
- Product Code
- MQL
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQL), ordered by most recent decision date.
Ultra-Fast Warm
FDA 510(k)
FDA Class 2
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CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
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FDA Class 2
·Obstetrics/Gynecology
Fast Warm - NX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ultra-Fast Vitri; Ultra-Fast Warm
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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| 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 |