FDA 510(k)

純淨範圍

K 號：K193161 · 2020-04-21

決定日期2020-04-21

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Pristine Scope is the device name listed in this FDA 510(k) record. The listed applicant is Pristine Surgical. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K193161. 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 Pristine Scope?

Pristine Scope is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Pristine Surgical. The 510(k) number is K193161.

When did Pristine Scope receive FDA 510(k) clearance?

Pristine Scope received FDA 510(k) clearance on 2020-04-21, under 510(k) number K193161.

Who is the listed applicant for Pristine Scope?

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

What is the FDA product code for Pristine Scope?

The FDA product code for Pristine Scope is GCJ.

其他以 Pristine Surgical 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。

K223244純淨關節鏡視覺系統 K183165純淨範圍

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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