SureStrip Vitrification Straw, SureLock Vitrification Straw
FDA 510(k) K203626 · Allwin Medical Devices, Inc.
510(k) numberK203626
Submission
- Device name
- SureStrip Vitrification Straw, SureLock Vitrification Straw
- Applicant
- Allwin Medical Devices, Inc.
Anaheim, CA, US - Received
- December 11, 2020
- Decision date
- June 4, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 SureStrip Vitrification Straw, SureLock Vitrification Straw cleared by the FDA?
SureStrip Vitrification Straw, SureLock Vitrification Straw (K203626) received a 510(k) decision of Substantially Equivalent on June 4, 2021, 175 days after the submission was received.
What is the product code of K203626?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.