# K991388: Assisted Hatching Micropipettes, Denuding Pipettes, Holding Micropipettes, Icsi Micropipettes, Partial Zone Dissection M

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Andrology, Inc.
- Decided: Sep 13, 1999 after 145 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Pacific Andrology, Inc. Microtools are a family of precision pipettes that are used for assisted reproduction procedures. They are designed, for use to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICS!, or other assisted reproduction methods. ICSI micropipettes are used for the intracytoplasmic single sperm injection of oocytes. Assisted hatching micropipettes are used to effect a hole in the zona pellucida by chemical means. The Holding Micropipettes are used to hold the oocyte in position during single sperm injection with the Intracytoplasmic sperm injection (ICSI) Micropipette, to hold the embryo during the assisted hatching or during partial zona dissection procedures. Partial zona dissection micropipettes are used to facilitate assisted hatching by mechanically creating a hole in the zona pellucida. The Denuding Pipettes are used to remove cumulus cell layers from oocytes.

Source page: https://510kreport.com/device/K991388
Methodology: https://510kreport.com/methodology