Cleared Special

Wallace Dual Lumen Oocyte Recovery System

K191291 · CooperSurgical, Inc. · Obstetrics & Gynecology
Jun 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K191291 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 June 12, 2019, 29 days after receiving the submission on May 14, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K191291 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2019
Decision Date June 12, 2019
Days to Decision 29 days
Submission Type Special
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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