Cleared Traditional

K173731 - SAGE Vitrification Kit (ART-8025 and AR...

K173731 is the FDA 510(k) clearance for SAGE Vitrification Kit (ART-8025 and AR... by CooperSurgical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K173731 · CooperSurgical, Inc. · Obstetrics & Gynecology device
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Mar 2018
Decision
86d
Days
Class 2
Risk

K173731 is an FDA 510(k) clearance for the SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming K.... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on March 2, 2018 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all CooperSurgical, Inc. devices

Submission Details

510(k) Number K173731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2017
Decision Date March 02, 2018
Days to Decision 86 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 160d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Origio A/S
Tove Kjaer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQL Media, Reproductive

All 121
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