FDA 510(k)

單次使用輸尿管進入鞘

K 號：K250695 · 2025-07-08

申請人Shenzhen HugeMed Medical Technical Development Co., Ltd.

決定日期2025-07-08

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

Single-use Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K250695. 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 Single-use Ureteral Access Sheath?

Single-use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K250695.

When did Single-use Ureteral Access Sheath receive FDA 510(k) clearance?

Single-use Ureteral Access Sheath received FDA 510(k) clearance on 2025-07-08, under 510(k) number K250695.

Who is the listed applicant for Single-use Ureteral Access Sheath?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Ureteral Access Sheath?

The FDA product code for Single-use Ureteral Access Sheath is FED.