Cleared Traditional

VitaVitro? Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro? Double Lumen Oocyte Retrieval Needle (ORND-17G)

K240523 · Shenzhen Vitavitro Biotech Co., Ltd. · Obstetrics & Gynecology
Nov 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K240523 is an FDA 510(k) clearance for the VitaVitro? Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro? Double Lumen Oocyte Retrieval Needle (ORND-17G), a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 15, 2024, 266 days after receiving the submission on February 23, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K240523 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2024
Decision Date November 15, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQE — Needle, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6100

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