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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 the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) 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. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K201086.

When did Advincula Delineator Uterine Manipulator receive FDA 510(k) clearance?

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

Who is the listed applicant for Advincula Delineator Uterine Manipulator?

The FDA 510(k) record lists CooperSurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing CooperSurgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243799Fetal PillowK250438CooperSurgical Milex® PessariesPMA P160047Device, thermal ablation, endometrialK223064ALLY II Uterine Positioning System™ (UPS)K200038Endosee SystemK191020G210 InviCell Plus with SignipHy pH monitoring

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Related Devices (Code: HEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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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