FDA 510(k)

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator

K番号: K170990 · 2017-05-11

決定日2017-05-11

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

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Spiration, Inc.. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K170990. 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 Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Spiration, Inc.. The 510(k) number is K170990.

When did Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator receive FDA 510(k) clearance?

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator received FDA 510(k) clearance on 2017-05-11, under 510(k) number K170990.

Who is the listed applicant for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

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

What is the FDA product code for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

The FDA product code for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is GEI.

申請者としてSpiration, Inc.を記載するその他の記録

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