FDA 510(k)

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

K番号: K163068 · 2016-12-22

決定日2016-12-22

製品コードFAD

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

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Q Urological Corporation. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K163068. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Q Urological Corporation. The 510(k) number is K163068.

When did pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent receive FDA 510(k) clearance?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent received FDA 510(k) clearance on 2016-12-22, under 510(k) number K163068.

Who is the listed applicant for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

The FDA 510(k) record lists Q Urological Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

The FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is FAD.

申請者としてQ Urological Corporationを記載するその他の記録

K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

公式ソース

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