# K161970: Follicle Aspiration Set

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Jun 14, 2017 after 331 days
- Product code: MQE (Needle, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991273 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991273: Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle, Swemed Lab International AB (1999) Summary page 4.

## Indications for use
Intended for flushing and/or aspiration of oocytes from ovarian follicles

Source page: https://510kreport.com/device/K161970
Methodology: https://510kreport.com/methodology