# K033903: Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes,

- Pathway: 510(k) (Special)
- Applicant: Cook Urological, Inc.
- Decided: Jan 16, 2004 after 30 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. The FDA summary names its predicate without a number.
- (no number) Intracytoplasmic Micropipet: named in the summary without a submission number
- (no number) 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: named in the summary without a submission number

## Most influential descendants
- K151018: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette (2016), 0 descendants of its own

## 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/K033903
Methodology: https://510kreport.com/methodology