# K983595: Transmyometrial Embryo Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Feb 8, 1999 after 118 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- 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) Intra-Endometrial Embryo Transfer Set: named in the summary without a submission number

## Most influential descendants
- K173431: Towako Transmyometrial Embryo Transfer Set (2018), 0 descendants of its own

## Indications for use
The Transmyometrial Embryo Transfer Sets are used for transferring I'VF embryo (s) into the endometrial cavity through the myometrium. These devices are sterile and intended for onc time use. The Transmyometerial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation. ccrvical stenosis or other cervical abnormalities which would preclude embryo transfer. a recent cesarcan section, a recent pregnancy (or is currcatly pregnant), or if a patient currently has an intrauterine device.

Source page: https://510kreport.com/device/K983595
Methodology: https://510kreport.com/methodology