# K033904: Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)

- Pathway: 510(k) (Special)
- Applicant: Cook Urological, Inc.
- Decided: Jan 16, 2004 after 30 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pipettes manufactured and distributed in Europe by Cook Australia: named in the summary without a submission number

## Most influential descendants
- K151018: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette (2016), 0 descendants of its own

## Indications for use
The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of Blastomeres for pre-implantation genetic diagnosis.

Source page: https://510kreport.com/device/K033904
Methodology: https://510kreport.com/methodology