FDA 510(k)

3M™ Ioban™ CHG クロレキシジングルコン酸切開被覆材（含有 2% w/w CHG）

K番号: K222578 · 2023-05-18

決定日2023-05-18

製品コードKKX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2023-05-18 under 510(k) number K222578. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is 3M Company. The 510(k) number is K222578.

When did 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) receive FDA 510(k) clearance?

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) received FDA 510(k) clearance on 2023-05-18, under 510(k) number K222578.

Who is the listed applicant for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?

The FDA product code for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is KKX.

申請者として3M Companyを記載するその他の記録

すべての50件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。