Cleared Special

Advincula Delineator Uterine Manipulator

K201086 · CooperSurgical, Inc. · Obstetrics & Gynecology
May 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201086 is an FDA 510(k) clearance for the Advincula Delineator Uterine Manipulator, a Culdoscope (and Accessories) (Class II — Special Controls, product code HEW), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on May 21, 2020, 28 days after receiving the submission on April 23, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1640.

Submission Details

510(k) Number K201086 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2020
Decision Date May 21, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HEW — Culdoscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1640

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