FDA · official record K250128Substantially Equivalent

Single Use Suction-Evacuation Ureteral Access Sheath

Name: Single Use Suction-Evacuation Ureteral Access Sheath — FDA K250128
Creator: Anhui Happiness Workshop Medical Instruments Co., Ltd.
Keywords: Single Use Suction-Evacuation Ureteral Access Sheath, Single Use Suction-Evacuation Ureteral Access Sheath, K250128, FED, FDA

United StatesFEDAnhui Happiness Workshop Medical Instruments Co., Ltd.

Verified

Official record identity

FDA application number: K250128
Decision date: September 19, 2025
Published decision: Substantially Equivalent

Classification

Product code: FED

Published parties

Applicant: Anhui Happiness Workshop Medical Instruments Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2025-01-17
Review panel: Gastroenterology, Urology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 876.1500

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.