FDA 510(k)

內視鏡噴霧塗裝器，配備旋轉盧爾斯

K 號：K162077 · 2016-08-11

申請人Micromedics, Inc. (D/B/A Nordson Medical)

決定日期2016-08-11

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Laparoscopic Spray Applicator with Spinning Luers is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K162077. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Laparoscopic Spray Applicator with Spinning Luers?

Laparoscopic Spray Applicator with Spinning Luers is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). The 510(k) number is K162077.

When did Laparoscopic Spray Applicator with Spinning Luers receive FDA 510(k) clearance?

Laparoscopic Spray Applicator with Spinning Luers received FDA 510(k) clearance on 2016-08-11, under 510(k) number K162077.

Who is the listed applicant for Laparoscopic Spray Applicator with Spinning Luers?

The FDA 510(k) record lists Micromedics, Inc. (D/B/A Nordson Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laparoscopic Spray Applicator with Spinning Luers?

The FDA product code for Laparoscopic Spray Applicator with Spinning Luers is GCJ.

其他以 Micromedics, Inc. (D/B/A Nordson Medical) 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K173385移植輸送，DePuy Synthes K172672內視鏡應用器，41公分

相關器械（代碼：GCJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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