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FDA 510(k)

SAGE Vitrification Kit and SAGE Vitrification Warming Kit

K-Number: K170560 · 2017-04-04

ApplicantCooperSurgical, Inc.
Decision Date2017-04-04
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SAGE Vitrification Kit and SAGE Vitrification Warming Kit is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2017-04-04 under approval number K170560. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

SAGE Vitrification Kit and SAGE Vitrification Warming Kit is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K170560.

When was SAGE Vitrification Kit and SAGE Vitrification Warming Kit approved by the FDA?

SAGE Vitrification Kit and SAGE Vitrification Warming Kit received FDA 510(k) clearance on 2017-04-04, under approval number K170560.

What company makes SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

SAGE Vitrification Kit and SAGE Vitrification Warming Kit is manufactured by CooperSurgical, Inc..

What is the FDA product code for SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

The FDA product code for SAGE Vitrification Kit and SAGE Vitrification Warming Kit is MQL.

Related Clinical Trials

NCT06238570 Validation of Donor Oocytes Semi-automated Vitrification RECRUITING

Other Devices by CooperSurgical, Inc.

K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula K180429Advincula Delineator Uterine Manipulator K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) K191291Wallace Dual Lumen Oocyte Recovery System K190639Endosee System

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Related Devices (Code: MQL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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