# K991700: Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/ZO

- Pathway: 510(k) (Traditional)
- Applicant: Swemed Lab International AB
- Decided: Jul 19, 1999 after 62 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) Cook OB/GYN Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes: named in the summary without a submission number

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

## Indications for use
The Swemed 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 during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove the cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.

Source page: https://510kreport.com/device/K991700
Methodology: https://510kreport.com/methodology