FDA 510(k)

史特劳斯外科膀胱鏡、宮頸鏡及配件儀器

K 號：K260271 · 2026-03-27

決定日期2026-03-27

產品代碼FAJ

諮詢委員會GU

決定相當於

器材摘要

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Endoscopy, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K260271. 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 Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is American Medical Endoscopy, Inc.. The 510(k) number is K260271.

When did Strauss Surgical cystoscope, hysteroscope and accessories Instruments receive FDA 510(k) clearance?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260271.

Who is the listed applicant for Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

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

What is the FDA product code for Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

The FDA product code for Strauss Surgical cystoscope, hysteroscope and accessories Instruments is FAJ.

其他以 American Medical Endoscopy, 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。

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.K253226UV5000W把手Uroviu Corporation K251140澗流春範Zenflow, Inc.

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。