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Disposable Ureteral Access Sheath

by Youcare Technology Co., Ltd. (Wuhan)

510(k) K230748

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230748 Date2 Aug 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FED
FDA applicant
Youcare Technology Co.,Ltd. (Wuhan)
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Disposable Ureteral Access Sheath is an endoscopic access overtube used in urological procedures. It provides access during endoscopic interventions in the urinary tract.

This device is supplied as a single-use, disposable product and is not intended for reuse. It is a Class 2 medical device with FDA 510(k) clearance under product code FED for use in gastroenterology and urology.

Other devices from Youcare Technology Co., Ltd. (Wuhan)