FDA 510(k)

インジー・リップストップ・リデployable・リトリーブ・システム

K番号: K232880 · 2023-11-01

申請者Applied Medical Resources Corporation

決定日2023-11-01

製品コードGCJ

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

Inzii Ripstop Redeployable Retrieval System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2023-11-01 under 510(k) number K232880. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Inzii Ripstop Redeployable Retrieval System?

Inzii Ripstop Redeployable Retrieval System is a medical device that received FDA 510(k) clearance on 2023-11-01. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K232880.

When did Inzii Ripstop Redeployable Retrieval System receive FDA 510(k) clearance?

Inzii Ripstop Redeployable Retrieval System received FDA 510(k) clearance on 2023-11-01, under 510(k) number K232880.

Who is the listed applicant for Inzii Ripstop Redeployable Retrieval System?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inzii Ripstop Redeployable Retrieval System?

The FDA product code for Inzii Ripstop Redeployable Retrieval System is GCJ.

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