FDA 510(k)

Cntrl+ Bladder Support Pessary

Номер K: K240798 · 2024-12-17

ЗаявительCntrl+, Inc.

Дата решения2024-12-17

Код продуктаHHW

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

Cntrl+ Bladder Support Pessary is the device name listed in this FDA 510(k) record. The listed applicant is Cntrl+, Inc.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K240798. 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 Cntrl+ Bladder Support Pessary?

Cntrl+ Bladder Support Pessary is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Cntrl+, Inc.. The 510(k) number is K240798.

When did Cntrl+ Bladder Support Pessary receive FDA 510(k) clearance?

Cntrl+ Bladder Support Pessary received FDA 510(k) clearance on 2024-12-17, under 510(k) number K240798.

Who is the listed applicant for Cntrl+ Bladder Support Pessary?

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

What is the FDA product code for Cntrl+ Bladder Support Pessary?

The FDA product code for Cntrl+ Bladder Support Pessary 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.K232677Reia pessaryReia, LLC K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.K231786Gynethotics™ PessaryCosm Medical

Официальный источник

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