FDA 510(k)

All-Suture Двухконтурная Система

Номер K: K250095 · 2025-09-05

Дата решения2025-09-05

Код продуктаMBI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

All-Suture Dual Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is Suturetech, Inc.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250095. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the All-Suture Dual Anchor System?

All-Suture Dual Anchor System is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Suturetech, Inc.. The 510(k) number is K250095.

When did All-Suture Dual Anchor System receive FDA 510(k) clearance?

All-Suture Dual Anchor System received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250095.

Who is the listed applicant for All-Suture Dual Anchor System?

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

What is the FDA product code for All-Suture Dual Anchor System?

The FDA product code for All-Suture Dual Anchor System is MBI.

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: MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262809ArthroTAK набор для анкеров тениArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Официальный источник

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