# K161275: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

- Pathway: 510(k) (Traditional)
- Applicant: Research Instruments Limited
- Decided: Jan 23, 2017 after 262 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K250838: Denudation Pipettes (2025), 0 descendants of its own
- K192146: V-Denupet (2020), 0 descendants of its own

## Indications for use
EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos. The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.

Source page: https://510kreport.com/device/K161275
Methodology: https://510kreport.com/methodology