# K990350: Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Jul 26, 1999 after 171 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 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 no predicate by 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
- K023379: Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction Catheter (2002), 1 descendant of its own
- K253354: Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (2026), 0 descendants of its own
- K243373: Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) (2025), 0 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1241-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1239-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1243-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1240-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1244-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1242-2013: Unable to pass catheter through outer sheath during embryo transfer

## Indications for use
For the introduction of embryo(s) or washed spermatozoa into the uterine cavity during assisted reproductive procedures

Source page: https://510kreport.com/device/K990350
Methodology: https://510kreport.com/methodology