FDA 510(k)

ELEOS末梢保護システム featuring BIOGRIP

K番号: K203090 · 2020-12-11

決定日2020-12-11

製品コードJDI

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

ELEOS Limb Salvage System featuring BIOGRIP is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K203090. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the ELEOS Limb Salvage System featuring BIOGRIP?

ELEOS Limb Salvage System featuring BIOGRIP is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Onkos Surgical. The 510(k) number is K203090.

When did ELEOS Limb Salvage System featuring BIOGRIP receive FDA 510(k) clearance?

ELEOS Limb Salvage System featuring BIOGRIP received FDA 510(k) clearance on 2020-12-11, under 510(k) number K203090.

Who is the listed applicant for ELEOS Limb Salvage System featuring BIOGRIP?

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

What is the FDA product code for ELEOS Limb Salvage System featuring BIOGRIP?

The FDA product code for ELEOS Limb Salvage System featuring BIOGRIP is JDI.

申請者としてOnkos Surgicalを記載するその他の記録

K212815マイ3D® パーソナライズド骨盤再建 K211677ELEOS末梢救済システム K203815ELEOS末梢保護システムおよびBioGrip K203588ELEOS™ 足保存システム

公式ソース

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