FDA 510(k)

Optimos™ 膀胱刀

K 號：K223256 · 2023-04-05

決定日期2023-04-05

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

Optimos™ Cystotome is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K223256. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optimos™ Cystotome?

Optimos™ Cystotome is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K223256.

When did Optimos™ Cystotome receive FDA 510(k) clearance?

Optimos™ Cystotome received FDA 510(k) clearance on 2023-04-05, under 510(k) number K223256.

Who is the listed applicant for Optimos™ Cystotome?

The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optimos™ Cystotome?

The FDA product code for Optimos™ Cystotome is KNS.

其他以 Taewoong Medical Co., Ltd. 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。

K260962括約肌切除器 K252648Niti-S SPAXUS支架 K251123Niti-S 膽道支架；Niti-S 膽道 Slim M 支架 K243619Niti-S 食管支架；食管TTS支架 K250663Niti-S 十二指腸舒適支架，Niti-S 大腸舒適支架 K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

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相關器械（代碼：KNS）

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。

K262460Rezum系統Boston Scientific K260962括約肌切除器Taewoong Medical Co., Ltd.K252388征服水蒸氣消融設備Francis Medical, Inc.K252889單次使用3 lumens針刀V型（KD-V441M，KD-V451M）Olympus Medical Systems Corporation K250945單次使用預裝式括約肌斷刀V型（遠端導絲導引）(KD-VC600系列)；單次使用括約肌斷刀V型（遠端導絲導引）(KD-VC400系列)；單次使用3腔括約肌斷刀(KD-V系列)；一次性三腔括約肌斷刀(KD系列)Olympus Medical Systems Corp.K250351單次使用電外科刀（KD-612L，KD-612U）；單次使用電外科刀（KD-620UR）；單次使用電外科刀（KD-650L，KD-650U）Olympus Medical Systems Corporation

官方來源

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