# K151018: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jan 8, 2016 after 267 days
- Product code: MQH (Microtools, Assisted Reproduction (Pipettes))
- Device class: 2
- Regulation: 21 CFR 884.6130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033904 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033904: Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes), Cook Urological, Inc. (2004) Summary page 5.
- K033903: Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes,, Cook Urological, Inc. (2004) Summary page 5.

## Indications for use
The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection. The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection. The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied testicular tissue.

Source page: https://510kreport.com/device/K151018
Methodology: https://510kreport.com/methodology