Nest VT Vitrification Device
FDA 510(k) K233177 · Cook Incorporated
510(k) numberK233177
Submission
- Device name
- Nest VT Vitrification Device
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- September 28, 2023
- Decision date
- March 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQK – Labware, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6160
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Nest VT Vitrification Device cleared by the FDA?
Nest VT Vitrification Device (K233177) received a 510(k) decision of Substantially Equivalent on March 8, 2024, 162 days after the submission was received.
What is the product code of K233177?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.