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FDA 510(k)

SimpleSnip內視鏡縫合剪（SC500160）；SimpleSnip內視鏡縫合剪（SC500230）

K 號：K242923 · 2024-12-20

申請人Envision Endoscopy
決定日期2024-12-20
產品代碼OCZ
諮詢委員會GU
決定相當於

器材摘要

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is the device name listed in this FDA 510(k) record. The listed applicant is Envision Endoscopy. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242923. The device is classified under product code OCZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Envision Endoscopy. The 510(k) number is K242923.

When did SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) receive FDA 510(k) clearance?

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242923.

Who is the listed applicant for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

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

What is the FDA product code for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

The FDA product code for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is OCZ.

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。

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其他以 Envision Endoscopy 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。

K243750SimpleStitch 緝合系統

相關器械（代碼：OCZ）

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。

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官方來源

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