FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
V-DENUPET
K Number: K192146
·
Decision Jan 28, 2020
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
7
Review Days
173
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Basic Information
- Device Name
- V-DENUPET
- K Number
- K192146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6130
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitromed GmbH
- Date Received
- August 8, 2019
- Decision Date
- January 28, 2020
- Product Code
- MQH
- 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 |
|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQH), ordered by most recent decision date.
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EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
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LifeGlobal Micro Tips
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Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
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Flexipet Denuding Pipette, Flexipet Manipulation Pipette
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FDA Class 2
·Obstetrics/Gynecology
BIOPSY PIPETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Vitromed GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K241833 | V-GRAD | Mar 21, 2025 | Substantially Equivalent |
| K240176 | V-VITFREEZE and V-VITWARM | Sep 13, 2024 | Substantially Equivalent |
| K232125 | V-PVP | Mar 20, 2024 | Substantially Equivalent |
| K222606 | V-HYADASE | May 26, 2023 | Substantially Equivalent |
| K223117 | V-SPERM WASH | Jan 31, 2023 | Substantially Equivalent |
| K193285 | V-ONESTEP | Nov 20, 2020 | Substantially Equivalent |