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SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)

K173731 Class II Traditional
Decision Date
2018-03-02
Sponsor / Applicant
CooperSurgical, Inc.

Technical Specification

510(k) Submission ID K173731
Product Code MQL
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.6180
Decision Date 2018-03-02
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) received FDA 510(k) clearance under submission number K173731, sponsored by CooperSurgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2018-03-02.

Classification & Regulation

This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.