# K990349: Wallace Malleable Stylet-18CM, Model 1816ST, Wallace Malleable Stylet-23CM, Model 1816NST

- 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.
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 no predicate by number.

## Most influential descendants
- K053208: Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial Transfer Catheter Set (2006), 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
The Family of Wallace Malleable Stylets are a sterile single-use device intended to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded.

Source page: https://510kreport.com/device/K990349
Methodology: https://510kreport.com/methodology