FDA 510(k)

Celerity™ 20 HP 生物指示標

K 號：K252680 · 2025-09-24

決定日期2025-09-24

產品代碼FRC

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Celerity™ 20 HP Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K252680. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Celerity™ 20 HP Biological Indicator?

Celerity™ 20 HP Biological Indicator is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is STERIS Corporation. The 510(k) number is K252680.

When did Celerity™ 20 HP Biological Indicator receive FDA 510(k) clearance?

Celerity™ 20 HP Biological Indicator received FDA 510(k) clearance on 2025-09-24, under 510(k) number K252680.

Who is the listed applicant for Celerity™ 20 HP Biological Indicator?

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

What is the FDA product code for Celerity™ 20 HP Biological Indicator?

The FDA product code for Celerity™ 20 HP Biological Indicator is FRC.

其他以 STERIS Corporation 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。

K261055AMSCO 700 鋰氣滅菌器 K260766Celerity 5 HP 生物指示標（LCB052）K251666系統1E 液體化學消毒劑處理系統，型號P6700；系統1內科液體化學消毒劑處理系統，型號P6900 K251048Rapicide PA 高級消毒試紙模型參考編號 = ML02-0118 K243876驗證蒸汽整合指示器 K250842鎖形釘 EFTR 套件 (00713229)

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相關器械（代碼：FRC）

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。

K260766Celerity 5 HP 生物指示標（LCB052）STERIS Corporation K251122Terragene® Bionova® BT20 生物指示劑Terragene K251452Celerity 5 HP 生物指示標（LCB052）；Celerity 5 HP 挑戰包（LCB059）；Celerity 20 HP 生物指示標（LCB044）；Celerity 20 HP 挑戰包（LCB045）Steris K250061Celerity IncubatorSTERIS Corporation K250044Celerity 5 HP 生物指示標（LCB052）；Celerity 5 HP 挑戰包（LCB059）；Celerity 20 HP 生物指示標（LCB044）；Celerity 20 HP 挑戰包（LCB045）STERIS Corporation K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M3M Company

官方來源

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