FDA 510(k)

STERiJECT 眼科針；STERiJECT 眼科針低死空間（LDS）

K番号: K242073 · 2024-10-23

申請者Tsk Laboratory International Japan KK

決定日2024-10-23

製品コードQYM

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory International Japan KK. It received FDA 510(k) clearance on 2024-10-23 under 510(k) number K242073. The device is classified under product code QYM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)?

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is Tsk Laboratory International Japan KK. The 510(k) number is K242073.

When did STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) receive FDA 510(k) clearance?

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) received FDA 510(k) clearance on 2024-10-23, under 510(k) number K242073.

Who is the listed applicant for STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)?

The FDA 510(k) record lists Tsk Laboratory International Japan KK as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)?

The FDA product code for STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is QYM.

申請者としてTsk Laboratory International Japan KKを記載するその他の記録

K231734STERiJECT 低死空間、STERiJECT 見えない針

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