FDA 510(k)

CiRX 一回使用電気外科ペン（非被覆および被覆電極）

K番号: K213786 · 2022-06-27

決定日2022-06-27

製品コードGEI

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

CiRX Single use electrosurgical pencil with non-coated and coated electrode is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. It received FDA 510(k) clearance on 2022-06-27 under 510(k) number K213786. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CiRX Single use electrosurgical pencil with non-coated and coated electrode?

CiRX Single use electrosurgical pencil with non-coated and coated electrode is a medical device that received FDA 510(k) clearance on 2022-06-27. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. The 510(k) number is K213786.

When did CiRX Single use electrosurgical pencil with non-coated and coated electrode receive FDA 510(k) clearance?

CiRX Single use electrosurgical pencil with non-coated and coated electrode received FDA 510(k) clearance on 2022-06-27, under 510(k) number K213786.

Who is the listed applicant for CiRX Single use electrosurgical pencil with non-coated and coated electrode?

The FDA 510(k) record lists Ningbo Shun YE Medical Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CiRX Single use electrosurgical pencil with non-coated and coated electrode?

The FDA product code for CiRX Single use electrosurgical pencil with non-coated and coated electrode is GEI.

申請者としてNingbo Shun YE Medical Company, Ltd.を記載するその他の記録

K210256CiRx (R) 外科マスク

公式ソース

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