FDA 510(k)

標準緩坡燈芯棒，38 Fr.

K 號：K222085 · 2022-10-31

決定日期2022-10-31

產品代碼KNT

諮詢委員會GU

決定相當於

器材摘要

Standard Tapered Bougie, 38 Fr. is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics, Inc.. It received FDA 510(k) clearance on 2022-10-31 under 510(k) number K222085. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Standard Tapered Bougie, 38 Fr.?

Standard Tapered Bougie, 38 Fr. is a medical device that received FDA 510(k) clearance on 2022-10-31. The listed applicant is Standard Bariatrics, Inc.. The 510(k) number is K222085.

When did Standard Tapered Bougie, 38 Fr. receive FDA 510(k) clearance?

Standard Tapered Bougie, 38 Fr. received FDA 510(k) clearance on 2022-10-31, under 510(k) number K222085.

Who is the listed applicant for Standard Tapered Bougie, 38 Fr.?

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

What is the FDA product code for Standard Tapered Bougie, 38 Fr.?

The FDA product code for Standard Tapered Bougie, 38 Fr. is KNT.

其他以 Standard Bariatrics, 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。

K231603標準釘線強化（SSLR23）

相關器械（代碼：KNT）

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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