# K991273: Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Swemed Lab International AB
- Decided: Aug 18, 1999 after 127 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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 Ovum Pick-Up Aspiration Needles, Single Lumen and Double Lumen: named in the summary without a submission number
- (no number) Swemed Needle For Amniocentesis And Cyst Puncture: named in the summary without a submission number

## Most influential descendants
- K082727: Follicle Aspiration Set, Reduced Single Lumen (2009), 3 descendants of its own
- K112462: Kitazato Opu Needle (2012), 1 descendant of its own
- K172050: Follicle Aspiration Set, Reduced Single Lumen (2017), 0 descendants of its own
- K162881: Kitazato OPU Needles (2017), 0 descendants of its own
- K161970: Follicle Aspiration Set (2017), 0 descendants of its own

## Indications for use
The Swemed Follicle Aspiration Set, Double Lumen; Swemed Follicle Aspiration Set, Single Lumen; and Swemed Follicle Aspiration Luer Needle and intended to obtain gametes from the body and are specifically indicated for flushing and/or aspiration of oocytes from ovarian follicles.

Source page: https://510kreport.com/device/K991273
Methodology: https://510kreport.com/methodology