FDA 510(k)

Ancora-SB

K 號：K231323 · 2023-08-31

決定日期2023-08-31

產品代碼FDA

諮詢委員會GU

決定相當於

器材摘要

Ancora-SB is the device name listed in this FDA 510(k) record. The listed applicant is Aspero Medical, Inc.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K231323. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ancora-SB?

Ancora-SB is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Aspero Medical, Inc.. The 510(k) number is K231323.

When did Ancora-SB receive FDA 510(k) clearance?

Ancora-SB received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231323.

Who is the listed applicant for Ancora-SB?

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

What is the FDA product code for Ancora-SB?

The FDA product code for Ancora-SB is FDA.

其他以 Aspero Medical, Inc. 為申請人之記錄

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K260314Ancora-SB

相關器械（代碼：FDA）

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。

K260314Ancora-SBAspero Medical, Inc.K251204富士通 stiffening wire device (SW-2000)FUJIFILM Healthcare Americas Corporation K233321雙球囊內視鏡 EN-840T，超管 TS-1214CFUJIFILM Healthcare Americas Corporation K223295內視鏡型號 EN-580T，過管 TS-1314B，氣球 BS-4，管套組 TY-500DFujifilm Corporaton K213195氣球 BS-3Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd.

官方來源

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