Cleared Special

ALLY II Uterine Positioning System? (UPS)

K223064 · CooperSurgical, Inc. · Obstetrics & Gynecology
Oct 2022
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K223064 is an FDA 510(k) clearance for the ALLY II Uterine Positioning System? (UPS), 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 October 28, 2022, 28 days after receiving the submission on September 30, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K223064 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date October 28, 2022
Days to Decision 28 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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