FDA 510(k)

Colonic Plus Regular, Small, and Straight Shape Hydrokit

Номер K: K180800 · 2018-06-01

ЗаявительColonic Plus

Дата решения2018-06-01

Код продуктаKPL

Консультативный комитетGU

РешениеUnknown

Описание устройства

Colonic Plus Regular, Small, and Straight Shape Hydrokit is the device name listed in this FDA 510(k) record. The listed applicant is Colonic Plus. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180800. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Часто задаваемые вопросы

What is the Colonic Plus Regular, Small, and Straight Shape Hydrokit?

Colonic Plus Regular, Small, and Straight Shape Hydrokit is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Colonic Plus. The 510(k) number is K180800.

When did Colonic Plus Regular, Small, and Straight Shape Hydrokit receive FDA 510(k) clearance?

Colonic Plus Regular, Small, and Straight Shape Hydrokit received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180800.

Who is the listed applicant for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

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

What is the FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

The FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit is KPL.

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: KPL)

K201861Bio Fluff SystemGnali Bocia S.R.L.K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.

Официальный источник

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