# K014160: PGD-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Feb 8, 2002 after 51 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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

## Indications for use
The Pre-Trnplantation Genetic Diagnosis Pipettes are used for the aspiration of blastomeres for pre-implantation genetic diagnosis. These devices are intended for one-time us¢ and will be marketed sterile. This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic matecia) in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the individual laboratorics for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been clearcd or approved by the Food and Drug Administration.

Source page: https://510kreport.com/device/K014160
Methodology: https://510kreport.com/methodology