FDA 510(k)

Accordion Piccolo Stone Management Device

Номер K: K172299 · 2017-09-19

ЗаявительThs International, Inc. D/B/A Accordion Medical

Дата решения2017-09-19

Код продуктаFFL

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Accordion Piccolo Stone Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Ths International, Inc. D/B/A Accordion Medical. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K172299. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Accordion Piccolo Stone Management Device?

Accordion Piccolo Stone Management Device is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Ths International, Inc. D/B/A Accordion Medical. The 510(k) number is K172299.

When did Accordion Piccolo Stone Management Device receive FDA 510(k) clearance?

Accordion Piccolo Stone Management Device received FDA 510(k) clearance on 2017-09-19, under 510(k) number K172299.

Who is the listed applicant for Accordion Piccolo Stone Management Device?

The FDA 510(k) record lists Ths International, Inc. D/B/A Accordion Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accordion Piccolo Stone Management Device?

The FDA product code for Accordion Piccolo Stone Management Device is FFL.

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.

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Связанные устройства (Код: FFL)

K190492Peralta Stone Removal CatheterCalcula Technologies, Inc.

Официальный источник

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