Cleared Special

Ally Uterine Positioning System

K153092 · CooperSurgical, Inc. · Obstetrics & Gynecology
Dec 2015
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K153092 is an FDA 510(k) clearance for the Ally Uterine Positioning System, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on December 21, 2015, 56 days after receiving the submission on October 26, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K153092 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2015
Decision Date December 21, 2015
Days to Decision 56 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code LKF — Cannula, Manipulator/injector, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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