Cleared Traditional

Oocyte Flushing & Retrieval Medium; Gamete Buffer

K234023 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology
May 2024
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K234023 is an FDA 510(k) clearance for the Oocyte Flushing & Retrieval Medium; Gamete Buffer, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shezhen, CN). The FDA issued a Cleared decision on May 10, 2024, 142 days after receiving the submission on December 20, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K234023 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2023
Decision Date May 10, 2024
Days to Decision 142 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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