免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Medline ReNewal 再生處理 Endopath 絶締內視鏡儀器

K 號：K152313 · 2016-01-06

申請人Surgical Instrument Services and Savings, Inc.
決定日期2016-01-06
產品代碼NUJ
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Medline ReNewal Reprocessed Endopath Endoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Services and Savings, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K152313. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed Endopath Endoscopic Instruments?

Medline ReNewal Reprocessed Endopath Endoscopic Instruments is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Surgical Instrument Services and Savings, Inc.. The 510(k) number is K152313.

When did Medline ReNewal Reprocessed Endopath Endoscopic Instruments receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Endopath Endoscopic Instruments received FDA 510(k) clearance on 2016-01-06, under 510(k) number K152313.

Who is the listed applicant for Medline ReNewal Reprocessed Endopath Endoscopic Instruments?

The FDA 510(k) record lists Surgical Instrument Services and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Endopath Endoscopic Instruments?

The FDA product code for Medline ReNewal Reprocessed Endopath Endoscopic Instruments is NUJ.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Surgical Instrument Services and Savings, 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。

K232130Medline ReNewal 再生 ViewFlex Xtra ICE 球囊電極导管K162751Medline ReNewal 再生處理 Ligasure Curved 小咬合開封/分離器

相關器械（代碼：NUJ）

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。

K232511Medline ReNewal 再生處理 LigaSure Exact Dissector, 細膠膜塗層 (LF2019)Surgical Instrument Service and Savings, Inc.K230251重製LigaSure Curved, 小咬合，開放式封合/分離器 (LF1212A)Stryker Sustainability SolutionsK220411重製LigaSure Curved, 小咬合，開放式封合/分離器 (LF1212A)Stryker Sustainability SolutionsK211203綠色或再處理Aquamantys雙極封合器Green Or, LLCK191073Vein360 静脈內放射頻率消融 (RFA) 穿刺針Vein 360, LLCK182588Medline ReNewal 再生處理 LigaSure Maryland 齒齒封閉器/分隔器Surgical Instrument Service and Savings Inc.(Dba Medline Ren

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。

↑