Cleared Traditional

Wallace Dual Lumen Oocyte Recovery System

K182959 · CooperSurgical, Inc. · Obstetrics & Gynecology
May 2019
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K182959 is an FDA 510(k) clearance for the Wallace Dual Lumen Oocyte Recovery System, a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on May 10, 2019, 197 days after receiving the submission on October 25, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K182959 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2018
Decision Date May 10, 2019
Days to Decision 197 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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