# K983596: Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Feb 5, 1999 after 115 days
- Product code: MQH (Microtools, Assisted Reproduction (Pipettes))
- Device class: 2
- Regulation: 21 CFR 884.6130
- Recalls of this device: 3 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Intracytoplasmic Micropipet and Holding Micropipet: named in the summary without a submission number
- (no number) Laboratory Micropipette Art. No. 33311: named in the summary without a submission number
- (no number) Laboratory Micropipette Art. No. 22218: named in the summary without a submission number
- (no number) ICSI pipettes, holding pipettes, denuding pipettes and assisted hatching/zona drilling pipettes manufactured and distributed in Europe by Cook Australia: named in the summary without a submission number

## Most influential descendants
- K024302: Precision Capillaries for Micromanipulation (2003), 0 descendants of its own

## Recalls of this device
- Mar 2, 2008 · Not classified · Z-2177-2008: mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
- Mar 2, 2008 · Not classified · Z-2176-2008: mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
- Dec 17, 2007 · Not classified · Z-2178-2008: mislabeled - 300 micron flexipets were labeled as 80 microns

## Indications for use
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.

Source page: https://510kreport.com/device/K983596
Methodology: https://510kreport.com/methodology