MQH · Microtools, Assisted Reproduction (Pipettes)
Obstetrics/Gynecology · 21 CFR 884.6130 · Class 2
Overview
| Product Code | MQH |
|---|---|
| Device Name | Microtools, Assisted Reproduction (Pipettes) |
| Regulation | 21 CFR 884.6130 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Cleared Devices (26)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250838 | Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. | Jul 3, 2025 | SESE |
| K192146 | V-DENUPET | Vitromed GmbH | Jan 28, 2020 | SESE |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited | Jan 23, 2017 | SESE |
| K152581 | LifeGlobal Micro Tips | Life Global Group, LLC | Apr 11, 2016 | SESE |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | Cook Incorporated | Jan 8, 2016 | SESE |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Cook Incorporated | Dec 18, 2015 | SESE |
| K133257 | BIOPSY PIPETTES | Research Instruments , Ltd. | May 16, 2014 | SESE |
| K102480 | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA | Jieying Laboratory, Inc. | Apr 19, 2011 | SESE |
| K092554 | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | Sunlight Medical, Inc. | Apr 30, 2010 | SESE |
| K072600 | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES | Sunlight Medical, Inc. | May 19, 2008 | SESE |
| K041435 | THE STRIPPER PGD | Mid-Atlantic Diagnostics, Inc. | Sep 29, 2004 | SESE |
| K041562 | CRYOTIP | Irvine Scientific Sales Co., Inc. | Aug 9, 2004 | SESE |
| K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) | Cook Urological, Inc. | Jan 16, 2004 | SESE |
| K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, | Cook Urological, Inc. | Jan 16, 2004 | SESE |
| K024302 | PRECISION CAPILLARIES FOR MICROMANIPULATION | Brinkmann Instruments, Inc. | Feb 19, 2003 | SESE |
| K022643 | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | Swemed Lab International AB | Nov 5, 2002 | SESE |
| K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B | Humagen Fertility Diagnostics, Inc. | Feb 11, 2002 | SESE |
| K001615 | HUNTER SCIENTIFIC INJECTION PIPETTES | Hunter Scientific Limited | Aug 18, 2000 | SESE |
| K993699 | THE STRIPPER | Mid-Atlantic Diagnostics, Inc. | May 16, 2000 | SESE |
| K991388 | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M | Pacific Andrology, Inc. | Sep 13, 1999 | SESE |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET | Research Instruments , Ltd. | Aug 5, 1999 | SESE |
| K991700 | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO | Swemed Lab International AB | Jul 19, 1999 | SESE |
| K991104 | MICROTOOLS | Conception Technology, Inc. | Jul 19, 1999 | SESE |
| K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M | Humagen Fertility Diagnostics, Inc. | Jul 14, 1999 | SESE |
| K983713 | PRODIMED MICROINJECTION PIPETTES | Prodimed | Jun 8, 1999 | SESE |
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | Cook Ob/Gyn | Feb 5, 1999 | SESE |
Top Applicants
- Swemed Lab International AB — 2 clearances
- Sunlight Medical, Inc. — 2 clearances
- Research Instruments , Ltd. — 2 clearances
- Mid-Atlantic Diagnostics, Inc. — 2 clearances
- Humagen Fertility Diagnostics, Inc. — 2 clearances
