FDA 510(k)

Altis Single Incision Sling System

K 號：K221874 · 2023-02-15

決定日期2023-02-15

產品代碼PAH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Altis Single Incision Sling System is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K221874. The device is classified under product code PAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Altis Single Incision Sling System?

Altis Single Incision Sling System is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Coloplast A/S. The 510(k) number is K221874.

When did Altis Single Incision Sling System receive FDA 510(k) clearance?

Altis Single Incision Sling System received FDA 510(k) clearance on 2023-02-15, under 510(k) number K221874.

Who is the listed applicant for Altis Single Incision Sling System?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altis Single Incision Sling System?

The FDA product code for Altis Single Incision Sling System is PAH.

其他以 Coloplast A/S 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。

K262045盧加軟件 K220420薑黃固定系統 K191536Biatain矽膠膚膚膠 K181811ReTrace 腎管進入鞘 K173527數碼特克斯遞送設備

相關器械（代碼：PAH）

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。

K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)Coloplast Corp.K191416Desara One單一切口吊帶系統，1包；Desara One單一切口吊帶系統，3包Caldera Medical, Inc.

官方來源

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