FDA 510(k)

LevaLap Laparoscopic Access Device

Номер K: K212786 · 2022-02-23

ЗаявительCore Access Surgical Technologies, Inc.

Дата решения2022-02-23

Код продуктаHIF

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

LevaLap Laparoscopic Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Core Access Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K212786. 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 LevaLap Laparoscopic Access Device?

LevaLap Laparoscopic Access Device is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Core Access Surgical Technologies, Inc.. The 510(k) number is K212786.

When did LevaLap Laparoscopic Access Device receive FDA 510(k) clearance?

LevaLap Laparoscopic Access Device received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212786.

Who is the listed applicant for LevaLap Laparoscopic Access Device?

The FDA 510(k) record lists Core Access Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LevaLap Laparoscopic Access Device?

The FDA product code for LevaLap Laparoscopic Access Device 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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