Cleared Traditional

K250838 - Denudation Pipettes

K250838 is an FDA 510(k) clearance for Denudation Pipettes, manufactured by Guangzhou Pinzhi Medical Device Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K250838 · Guangzhou Pinzhi Medical Device Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
105d
Days
Class 2
Risk

K250838 is an FDA 510(k) clearance for the Denudation Pipettes. Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Guangzhou Pinzhi Medical Device Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 3, 2025 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Guangzhou Pinzhi Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K250838

510(k) Number K250838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 160d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQH Device Classification - Class 2, Special Controls

Product Code MQH Microtools, Assisted Reproduction (pipettes)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Chonconn Consulting Co., Ltd.
Jie Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQH Microtools, Assisted Reproduction (pipettes)

All 7
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K250838.
V-DENUPET
K192146 · Vitromed GmbH · Jan 2020
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
K151018 · Cook Incorporated · Jan 2016
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · Cook Incorporated · Dec 2015
CRYOTIP
K041562 · Irvine Scientific Sales Co., Inc. · Aug 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K033903 · Cook Urological, Inc. · Jan 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · Cook Urological, Inc. · Jan 2004