# K983594: Embryo Transfer Catheters/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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 6 cite it directly.
0 of 15 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 Australia Embryo Transfer Catheters/Sets: named in the summary without a submission number

## Most influential descendants
- K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter (2003), 5 descendants of its own
- K162878: Kitazato ET Catheters (2017), 2 descendants of its own
- K173103: Pivet and Soft-Pass Embryo Transfer Catheter Sets (2018), 1 descendant of its own
- K173686: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter (2018), 1 descendant of its own
- K172051: Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter (2018), 1 descendant of its own

## Recalls of this device
- Oct 3, 2019 · Class II · Z-0415-2020: Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used inclu
- Oct 3, 2019 · Class II · Z-0416-2020: Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used inclu
- Dec 19, 2017 · Class II · Z-1188-2018: 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 Embryo Transfer Catheters/Sets are used to place embryos into the uterine cavity.

Source page: https://510kreport.com/device/K983594
Methodology: https://510kreport.com/methodology