FDA 510(k)

SteriTite Container System with MediTray Products

K番号: K252854 · 2026-06-03

決定日2026-06-03

製品コードKCT

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Substantially Equivalent

医療機器の概要

SteriTite Container System with MediTray Products is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K252854. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SteriTite Container System with MediTray Products?

SteriTite Container System with MediTray Products is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Case Medical, Inc.. The 510(k) number is K252854.

When did SteriTite Container System with MediTray Products receive FDA 510(k) clearance?

SteriTite Container System with MediTray Products received FDA 510(k) clearance on 2026-06-03, under 510(k) number K252854.

Who is the listed applicant for SteriTite Container System with MediTray Products?

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

What is the FDA product code for SteriTite Container System with MediTray Products?

The FDA product code for SteriTite Container System with MediTray Products is KCT.

申請者としてCase Medical, Inc.を記載するその他の記録

K221492SteriTite Container System with MediTray Parts K212711SteriTite Container System with MediTray Products K173259ケースメディカルステリティテリユースアブルレジッドステリライゼーションコンテナーシステムとメディトレイアクセサリー K161415SteriTite Containers System & MediTray Products

公式ソース

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