FDA 510(k)

無菌内視鏡生検採取針

K番号: K171956 · 2017-12-12

申請者Changzhou Detain Medical Devices Co., Ltd.

決定日2017-12-12

製品コードFCG

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

Sterile Endoscope Biopsy Sampling Needle is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Detain Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K171956. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterile Endoscope Biopsy Sampling Needle?

Sterile Endoscope Biopsy Sampling Needle is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Changzhou Detain Medical Devices Co., Ltd.. The 510(k) number is K171956.

When did Sterile Endoscope Biopsy Sampling Needle receive FDA 510(k) clearance?

Sterile Endoscope Biopsy Sampling Needle received FDA 510(k) clearance on 2017-12-12, under 510(k) number K171956.

Who is the listed applicant for Sterile Endoscope Biopsy Sampling Needle?

The FDA 510(k) record lists Changzhou Detain Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Endoscope Biopsy Sampling Needle?

The FDA product code for Sterile Endoscope Biopsy Sampling Needle is FCG.

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無菌内視鏡生検採取針

医療機器の概要

よくある質問

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