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FDA 510(k)

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

K-Number: K161065 · 2016-10-27

ApplicantSurgitools Pty , Ltd.
Decision Date2016-10-27
Product CodeHEW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is Surgitools Pty , Ltd.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K161065. 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 ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator?

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Surgitools Pty , Ltd.. The 510(k) number is K161065.

When did ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator receive FDA 510(k) clearance?

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator received FDA 510(k) clearance on 2016-10-27, under 510(k) number K161065.

Who is the listed applicant for ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator?

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

What is the FDA product code for ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator?

The FDA product code for ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator is HEW.

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.K201086Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.K191294Transvaginal Access PlatformApplied Medical Resources Corp.K180429Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.

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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