FDA 510(k)

空間OAR系統

K 號：K181465 · 2018-06-25

決定日期2018-06-25

產品代碼OVB

諮詢委員會RA

決定相當於

器材摘要

SpaceOAR System is the device name listed in this FDA 510(k) record. The listed applicant is Augmenix, Inc.. It received FDA 510(k) clearance on 2018-06-25 under 510(k) number K181465. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpaceOAR System?

SpaceOAR System is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Augmenix, Inc.. The 510(k) number is K181465.

When did SpaceOAR System receive FDA 510(k) clearance?

SpaceOAR System received FDA 510(k) clearance on 2018-06-25, under 510(k) number K181465.

Who is the listed applicant for SpaceOAR System?

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

What is the FDA product code for SpaceOAR System?

The FDA product code for SpaceOAR System is OVB.

其他以 Augmenix, Inc. 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。

K182971SpaceOAR Vue 水凝胶

相關器械（代碼：OVB）

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。

K262151SpaceOAR Flex™ 系統Boston Scientific Corporation K260119SpaceOAR Vue 系統 (SV-2101)Boston Scientific Corporation K222972BioProtect 機械植入體™ 系統Bioprotect, Ltd.K220641Barrigel 注射用膠Palette Life Sciences K202224空間OAR系統Boston Scientific Corporation K182971SpaceOAR Vue 水凝胶Augmenix, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。