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)

湯普森腦拉引器臥床式（TM），湯普森腦拉引器頭蓋骨夾具式（SCM）

K 號：K210615 · 2022-05-13

申請人Thompson Surgical Instruments, Inc.
決定日期2022-05-13
產品代碼GZT
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is the device name listed in this FDA 510(k) record. The listed applicant is Thompson Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K210615. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Thompson Surgical Instruments, Inc.. The 510(k) number is K210615.

When did Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) receive FDA 510(k) clearance?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) received FDA 510(k) clearance on 2022-05-13, under 510(k) number K210615.

Who is the listed applicant for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

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

What is the FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

The FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is GZT.

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：GZT）

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。

K252995杜拉盾設備套件SurGenTec, LLCK202694Vycor醫療視覺導航系統（VBAS）及配對夾的VBAS（合稱為“VBAS系列”）Vycor Medical, Inc.K202072MindsEye 可擴充端口Minnetronix Neuro, Inc.K180610神經及脊椎手術用Geister拉钩Geister Medizin Technik GmbHK172433NICO 大腦通路Nico CorporationK161680醫康脊椎擴散系統Medicon EG

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。

↑