FDA 510(k)

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

K番号: K251852 · 2026-02-13

決定日2026-02-13

製品コードOWN

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

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is the device name listed in this FDA 510(k) record. The listed applicant is VPIX Medical, Inc.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251852. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is VPIX Medical, Inc.. The 510(k) number is K251852.

When did cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) receive FDA 510(k) clearance?

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251852.

Who is the listed applicant for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

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

What is the FDA product code for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

The FDA product code for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is OWN.

申請者としてVPIX Medical, Inc.を記載するその他の記録

K233391cCeLL - In vivo

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。