FDA 510(k)

重追溯輸尿管進入鞘（ASXL10、ASXL12、ACXL10、ACXL12、AXXL10、AXXL12、ALXL10、ALXL12）

K 號：K242173 · 2024-11-12

決定日期2024-11-12

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242173. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)?

Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Coloplast Corp.. The 510(k) number is K242173.

When did Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) receive FDA 510(k) clearance?

Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242173.

Who is the listed applicant for Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)?

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

What is the FDA product code for Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)?

The FDA product code for Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) is FED.

其他以 Coloplast Corp. 為申請人之記錄

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