FDA 510(k)

Revive Reusable Bladder Support

Номер K: K183468 · 2019-01-25

Дата решения2019-01-25

Код продуктаHHW

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

Revive Reusable Bladder Support is the device name listed in this FDA 510(k) record. The listed applicant is Rinovum Subsidiary 2, LLC. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K183468. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Revive Reusable Bladder Support?

Revive Reusable Bladder Support is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Rinovum Subsidiary 2, LLC. The 510(k) number is K183468.

When did Revive Reusable Bladder Support receive FDA 510(k) clearance?

Revive Reusable Bladder Support received FDA 510(k) clearance on 2019-01-25, under 510(k) number K183468.

Who is the listed applicant for Revive Reusable Bladder Support?

The FDA 510(k) record lists Rinovum Subsidiary 2, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revive Reusable Bladder Support?

The FDA product code for Revive Reusable Bladder Support is HHW.

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: HHW)

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper Surgical K250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLC K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.

Официальный источник

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