Atlas FDA

MQH

26 FDA 510(k) clearances · Product code

145 daysmedian time to decision
262 days90th percentile
26clearances measured

FDA profile

Official device name
Microtools, Assisted Reproduction (Pipettes)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6130
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2012: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Denudation Pipettes (K250838)Guangzhou Pinzhi Medical Device Co., Ltd.2025-07-03
V-DENUPET (K192146)Vitromed GmbH2020-01-28
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (K161275)Research Instruments Limited2017-01-23
LifeGlobal Micro Tips (K152581)Life Global Group, LLC2016-04-11
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette (K151018)Cook Incorporated2016-01-08
Flexipet Denuding Pipette, Flexipet Manipulation Pipette (K150748)Cook Incorporated2015-12-18
BIOPSY PIPETTES (K133257)Research Instruments , Ltd.2014-05-16
INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA (K102480)Jieying Laboratory, Inc.2011-04-19
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (K092554)Sunlight Medical, Inc.2010-04-30
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES (K072600)Sunlight Medical, Inc.2008-05-19
THE STRIPPER PGD (K041435)Mid-Atlantic Diagnostics, Inc.2004-09-29
CRYOTIP (K041562)Irvine Scientific Sales Co., Inc.2004-08-09
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) (K033904)Cook Urological, Inc.2004-01-16
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, (K033903)Cook Urological, Inc.2004-01-16
PRECISION CAPILLARIES FOR MICROMANIPULATION (K024302)Brinkmann Instruments, Inc.2003-02-19
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 (K022643)Swemed Lab International AB2002-11-05
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B (K012811)Humagen Fertility Diagnostics, Inc.2002-02-11
HUNTER SCIENTIFIC INJECTION PIPETTES (K001615)Hunter Scientific Limited2000-08-18
THE STRIPPER (K993699)Mid-Atlantic Diagnostics, Inc.2000-05-16
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M (K991388)Pacific Andrology, Inc.1999-09-13
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET (K991261)Research Instruments , Ltd.1999-08-05
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO (K991700)Swemed Lab International AB1999-07-19
MICROTOOLS (K991104)Conception Technology, Inc.1999-07-19
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M (K990847)Humagen Fertility Diagnostics, Inc.1999-07-14
PRODIMED MICROINJECTION PIPETTES (K983713)Prodimed1999-06-08
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING (K983596)Cook Ob/Gyn1999-02-05

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Every clearance here is in the API, with alerts when new ones post.