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)

HARMONIC HD 1000i 剪刀 20 公分長度，HARMONIC HD 1000i 剪刀 36 公分長度

K 號：K160752 · 2016-06-29

申請人Ethicon Endo-Suregery, LLC
決定日期2016-06-29
產品代碼LFL
決定相當於

器材摘要

HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Suregery, LLC. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160752. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常見問題

What is the HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length?

HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Ethicon Endo-Suregery, LLC. The 510(k) number is K160752.

When did HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length receive FDA 510(k) clearance?

HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160752.

Who is the listed applicant for HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length?

The FDA 510(k) record lists Ethicon Endo-Suregery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length?

The FDA product code for HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length is LFL.

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

相關器械（代碼：LFL）

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。

K261448neXus 超聲外科吸引器系統Misonix, LLCK251162CUSA® 清晰度超聲手術吸引器系統Integra LifeSciences CorporationK242894SanAgile™ 超聲手術先進攜帶控制器 (SA10)；SanAgile™ 超聲手術先進解剖刀 (SASD14)；SanAgile™ 超聲手術先進解剖刀 (SASD23)；SanAgile™ 超聲手術先進解剖刀 (SASD36)；SanAgile™ 超聲手術先進解剖刀 (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ 超聲吸引器系統 (5500-050-000)Stryker InstrumentsK241700Tenex 第二代系統Trice Medical, Inc.K240493CUSA® 清晰度超聲手術吸引器系統Integra LifeSciences Corporation

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。

↑