Cleared Special

Advincula Delineator Uterine Manipulator

K180429 · CooperSurgical, Inc. · Obstetrics & Gynecology
Mar 2018
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K180429 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 March 14, 2018, 26 days after receiving the submission on February 16, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1640.

Submission Details

510(k) Number K180429 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2018
Decision Date March 14, 2018
Days to Decision 26 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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