FDA.reportPublic FDA data

510(k) K250838

Device
Denudation Pipettes
Applicant
Guangzhou Pinzhi Medical Device Co., Ltd.
510(k) number
K250838
Product code
MQH
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-03
Date received
2025-03-20
Regulation
884.6130
Classification name
Microtools, Assisted Reproduction (Pipettes)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hestia Xu
Address
Rm. 405, 4th Floor, #600-2 Guangshan 2nd Rd. Fenghuang St., Tianhe District Guangzhou CN 510520 510520

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192146V-DENUPETVitromed GmbH2020-01-28
K161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments Limited2017-01-23
K152581LifeGlobal Micro TipsLife Global Group, LLC2016-04-11
K151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook Incorporated2016-01-08
K150748Flexipet Denuding Pipette, Flexipet Manipulation PipetteCook Incorporated2015-12-18
K133257BIOPSY PIPETTESResearch Instruments , Ltd.2014-05-16
K102480INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, Inc.2011-04-19
K092554BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTESSunlight Medical, Inc.2010-04-30
K072600INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTESSunlight Medical, Inc.2008-05-19
K041435THE STRIPPER PGDMid-Atlantic Diagnostics, Inc.2004-09-29
K041562CRYOTIPIrvine Scientific Sales Co., Inc.2004-08-09
K033903MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,Cook Urological, Inc.2004-01-16
K033904PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)Cook Urological, Inc.2004-01-16
K024302PRECISION CAPILLARIES FOR MICROMANIPULATIONBrinkmann Instruments, Inc.2003-02-19
K022643BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540Swemed Lab International AB2002-11-05