Cleared Traditional

K240002 - G-Vitri™ Vitrification Straw (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240002 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology device
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Jun 2024
Decision
164d
Days
Class 2
Risk

K240002 is an FDA 510(k) clearance for the G-Vitri™ Vitrification Straw. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 14, 2024 after a review of 164 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gimbo Medical Technology Shenzhen Co., Ltd. devices

Submission Details

510(k) Number K240002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2024
Decision Date June 14, 2024
Days to Decision 164 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 160d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 Peers - MQK Labware, Assisted Reproduction

All 49
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