FDA 510(k)

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

Номер K: K161065 · 2016-10-27

Дата решения2016-10-27

Код продуктаHEW

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: HEW)

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.

Официальный источник

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