Cleared Traditional

SureStrip Vitrification Straw, SureLock Vitrification Straw

K203626 · Allwin Medical Devices, Inc. · Obstetrics & Gynecology
Jun 2021
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K203626 is an FDA 510(k) clearance for the SureStrip Vitrification Straw, SureLock Vitrification Straw, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 4, 2021, 175 days after receiving the submission on December 11, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.

Submission Details

510(k) Number K203626 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2020
Decision Date June 04, 2021
Days to Decision 175 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MQK — Labware, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6160

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