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FDA 510(k)

Advincula Delineator Uterine Manipulator

K-Number: K201086 · 2020-05-21

ApplicantCooperSurgical, Inc.
Decision Date2020-05-21
Product CodeHEW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Advincula Delineator Uterine Manipulator is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2020-05-21 under approval number K201086. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advincula Delineator Uterine Manipulator?

Advincula Delineator Uterine Manipulator is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K201086.

When was Advincula Delineator Uterine Manipulator approved by the FDA?

Advincula Delineator Uterine Manipulator received FDA 510(k) clearance on 2020-05-21, under approval number K201086.

What company makes Advincula Delineator Uterine Manipulator?

Advincula Delineator Uterine Manipulator is manufactured by CooperSurgical, Inc..

What is the FDA product code for Advincula Delineator Uterine Manipulator?

The FDA product code for Advincula Delineator Uterine Manipulator is HEW.

Related Clinical Trials

NCT05687084 Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial RECRUITING

Other Devices by CooperSurgical, Inc.

K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula K170560SAGE Vitrification Kit and SAGE Vitrification Warming Kit K180429Advincula Delineator Uterine Manipulator K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) K191291Wallace Dual Lumen Oocyte Recovery System

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Related Devices (Code: HEW)

K161065ColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorSurgitools Pty , Ltd. K180429Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. K191294Transvaginal Access PlatformApplied Medical Resources Corp. K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceApplied Medical Resources Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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