# K991261: Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette, Assisted Hatching/Zona Drilling Micropipet

- Pathway: 510(k) (Traditional)
- Applicant: Research Instruments, Ltd.
- Decided: Aug 5, 1999 after 114 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K133257: Biopsy Pipettes (2014), 0 descendants of its own

## Indications for use
ICSI injection micropipettes are used for injecting spermatozoa into the cytoplasm of an oocyte during intracytoplasmic sperm injection (ICSI). Holding micropipettes are used to anchor the oocyte under vacuum during intracytoplasmic sperm injection (ICSI). Assisted hatching micropipettes are used to direct Tyrode’s solution onto the zona of an oocyte, thus creating a hole and enabling the oocyte to hatch. Denuding pipettes are used to strip the cumulus from oocytes prior to intracytoplasmic sperm injection (ICSI).

Source page: https://510kreport.com/device/K991261
Methodology: https://510kreport.com/methodology