Cleared Traditional

Denudation Pipettes

K250838 · Guangzhou Pinzhi Medical Device Co., Ltd. · Obstetrics & Gynecology

Jul 2025

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K250838 is an FDA 510(k) clearance for the Denudation Pipettes, a Microtools, Assisted Reproduction (pipettes) (Class II — Special Controls, product code MQH), submitted by Guangzhou Pinzhi Medical Device Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 3, 2025, 105 days after receiving the submission on March 20, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6130.

Submission Details

510(k) Number	K250838 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2025
Decision Date	July 03, 2025
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF