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FDA 510(k)

Surgify Halo (54.085.SHD.U1)；Surgify Halo (54.140.SHD. U1)；Surgify Halo (54.070.NVG.U1)；Surgify Halo (54.125.NVG.U1)；Surgify Halo (54.000.SEE.U1)；Surgify Halo (40.070.NVG.U1)；Surgify Halo (40.125.NVG.U1)；Surgify Halo (40.000.SEE.U1)；Surgify Halo (30.070.NVG.U2)；Surgify Halo (30.125.NVG.U2)；Surgify Halo (30.000.SEE.U2)

K 號：K253627 · 2026-03-26

申請人Surgify Medical OY
決定日期2026-03-26
產品代碼HBE
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

Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) is the device name listed in this FDA 510(k) record. The listed applicant is Surgify Medical OY. It received FDA 510(k) clearance on 2026-03-26 under 510(k) number K253627. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)?

Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is Surgify Medical OY. The 510(k) number is K253627.

When did Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) receive FDA 510(k) clearance?

Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) received FDA 510(k) clearance on 2026-03-26, under 510(k) number K253627.

Who is the listed applicant for Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)?

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

What is the FDA product code for Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)?

The FDA product code for Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) is HBE.

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 Surgify Medical OY 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。

K251433Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)；Surgify Halo (40.070.NVG.H1)；Surgify Halo (40.125.NVG.H1)；Surgify Halo (40.000.SEE.H1)K250380Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)K232684Surgify 銀河

相關器械（代碼：HBE）

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。

K250815Hubly 閱孔機 (H100)Hubly, Inc.K252060綠色Phasor Health, LLCK252662醫療設備名稱：UniBur 醫療設備規範文本：FDA、510(k)、PMA、NCT、PMID、識別碼及網址 政策：medical-regulatory-v1 翻譯結果：UniBurNakanishi, Inc.K251433Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)；Surgify Halo (40.070.NVG.H1)；Surgify Halo (40.125.NVG.H1)；Surgify Halo (40.000.SEE.H1)Surgify Medical OYK250380Surgify Halo (54.085.SHD.H1)；Surgify Halo (54.140.SHD.H1)；Surgify Halo (54.070.NVG.H1)；Surgify Halo (54.125.NVG.H1)；Surgify Halo (54.000.SEE.H1)Surgify Medical OYK250374iBur 3.0mm 鑽石匹配頭，遠端彎曲（8431-107-030D）；iBur 3.0mm 精準圓形，遠端彎曲（8431-009-030）；iBur 4.0mm 精準圓形，遠端彎曲（8431-009-040）；iBur 2.0mm 鑽石圓形，遠端彎曲（8431-012-020D）；iBur 3.0mm 鑽石圓形，遠端彎曲（8431-012-030D）；iBur 4.0mm 鑽石圓形，遠端彎曲（8431-012-040D）；iBur 3.0mm 粗鑽石圓形，遠端彎曲（8431-013-030DC）；iBur 4.0mm 粗鑽石圓形，遠端彎曲（8431-013-040DC）；iBur 5.0mm 粗鑽石圓形Stryker Instruments

官方來源

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