# K150748: Flexipet Denuding Pipette, Flexipet Manipulation Pipette

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 18, 2015 after 270 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 K993699 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993699: The Stripper, Mid-Atlantic Diagnostics, Inc. (2000) Summary page 4.

## Indications for use
The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, or denuding. The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.

Source page: https://510kreport.com/device/K150748
Methodology: https://510kreport.com/methodology