FDA 510(k)

TauTona Pneumoperitoneum Assist Device (TPAD)

Номер K: K233020 · 2024-01-12

ЗаявительTautona Group Research & Development, Co., LLC

Дата решения2024-01-12

Код продуктаHIF

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

TauTona Pneumoperitoneum Assist Device (TPAD) is the device name listed in this FDA 510(k) record. The listed applicant is Tautona Group Research & Development, Co., LLC. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233020. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TauTona Pneumoperitoneum Assist Device (TPAD)?

TauTona Pneumoperitoneum Assist Device (TPAD) is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Tautona Group Research & Development, Co., LLC. The 510(k) number is K233020.

When did TauTona Pneumoperitoneum Assist Device (TPAD) receive FDA 510(k) clearance?

TauTona Pneumoperitoneum Assist Device (TPAD) received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233020.

Who is the listed applicant for TauTona Pneumoperitoneum Assist Device (TPAD)?

The FDA 510(k) record lists Tautona Group Research & Development, Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD)?

The FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD) is HIF.

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: HIF)

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KG K242772AirSurgN Инфузор (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

Официальный источник

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