# K983591: Intratubal Transfer Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Dec 21, 1998 after 69 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: 1 (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) Embryo and Gamete Intratubal Transfer Sets: named in the summary without a submission number

## Most influential descendants
- K231730: FemaSeed Intratubal Insemination (2023), 0 descendants of its own

## Recalls of this device
- Dec 19, 2017 · Class II · Z-1186-2018: Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviab

## Indications for use
The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via ultrasound guidance. The device is sterile and intended for one time use.

Source page: https://510kreport.com/device/K983591
Methodology: https://510kreport.com/methodology