# K250838: Denudation Pipettes

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Pinzhi Medical Device Co., Ltd.
- Decided: Jul 3, 2025 after 105 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: 2 generations back to K993699 (2000). 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)
- K161275: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip, Research Instruments Limited (2017) Summary page 5.

## Indications for use
Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.

Source page: https://510kreport.com/device/K250838
Methodology: https://510kreport.com/methodology