FDA 510(k)

WiScope®數位膀胱鏡系統，WiScope®一次性使用數位柔軟膀胱鏡，WiScope®醫療平板電腦

K 號：K231702 · 2023-09-29

決定日期2023-09-29

產品代碼FAJ

諮詢委員會GU

決定相當於

器材摘要

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet is the device name listed in this FDA 510(k) record. The listed applicant is OTU Medical, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231702. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet?

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is OTU Medical, Inc.. The 510(k) number is K231702.

When did WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet receive FDA 510(k) clearance?

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231702.

Who is the listed applicant for WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet?

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

What is the FDA product code for WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet?

The FDA product code for WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet is FAJ.

其他以 OTU Medical, Inc. 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。

K220399WiScope數位支氣管內鏡系統，WiScope一次性使用數位柔軟支氣管內鏡，WiScope影像系統 K212202WiScope數位膀胱鏡系統，WiScope一次性使用數位柔軟膀胱鏡，WiScope影像系統 K210579WiScope OM 経鏡系統，WiScope 單次使用數字柔軟輸尿管鏡。總管鏡，WiScope 圖像系統 K181977WiScope數位內視鏡系統

相關器械（代碼：FAJ）

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。

K260649OES ELITE 膀胱鏡及附件；塞子，17 Fr.（WA2C17BO）；塞子，19.8 Fr.（WA2C19BO）；塞子，21 Fr.（WA2C21BO）；塞子，21 Fr.，配斜坡套管（WA2C21RO）；塞子，21 Fr.，長型（WA2C21LO）；塞子，21 Fr.，配直型套管（WA2C21SO）；塞子，22.5 Fr.（WA2C22BO）；塞子，25 Fr.（WA2C25BO）；光學塞子，19.8 Fr.（WA2C19BV）；光學塞子，21 Fr.（WA2C21BV）；光學塞子，21 Fr.，配直型套管（WA2C21SV）；光學塞子，Olympus Winter & Ibe GmbH K253696CFlex 膀胱鏡 - 标准偏轉 (0570-0455)；CFlex 膀胱鏡 - 反向偏轉 (0570-0456)；CystoView 監視器 (0570-0465)Verathon Medical (Canada) Ulc K253892Strauss外科電子膀胱鏡與宮腔鏡（STS-2040-302ASA HD內鏡，4 x 302 mm，視野。方向 0°，標準型，可蒸氣消毒）；Strauss外科電子膀胱鏡與宮腔鏡（STS-2040-302AA HD內鏡，4 x 302 mm，視野。方向 0°，廣角，可蒸氣消毒）；Strauss外科電子膀胱鏡與宮腔鏡（STS-2040-302BA HD內鏡，4 x 302 mm，視野。方向 30°，廣角，可蒸氣消毒）；Strauss外科電子膀胱鏡與宮腔鏡（STS-2040-302BSA HD內鏡，4 x 302 mm，視野。方向 30°，Strauss Surgical USA K253905PrimeSight UltraView 系統Cogentix Medical, Inc.K260271史特劳斯外科膀胱鏡、宮頸鏡及配件儀器American Medical Endoscopy, Inc.K253226UV5000W把手Uroviu Corporation

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。