# K023382: Coopersurgical Malleable Sytlet

- Pathway: 510(k) (Traditional)
- Applicant: Cooper Surgical
- Decided: Dec 20, 2002 after 73 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K930343: Wallace Malleable Stylets. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## 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

## Indications for use
The sterile single-use devices are to be used in conjunction with CooperSurgical Assisted Reproduction Catheters for in-vitro fertilization procedures where passage through the cervix is impeded.

Source page: https://510kreport.com/device/K023382
Methodology: https://510kreport.com/methodology