# K023383: Coopersurgical Intrauterine Insemination Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cooper Surgical
- Decided: Dec 13, 2002 after 66 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
Longest line of descent: 1 generation back to K964848 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964848: Wallace Artificial Insemination Catheter - 8CM/18CM, Marlow Surgical Technologies, Inc. (1997). Our reading of the summary gave K964818, FDA’s number for Orion Series Surgical Laser System (Q-Switched ND:Yag… (Laserscope). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Wallace Artificial Insemination Catheters”.

## Indications for use
The sterile single-use catheter is intended for introducing washed spermatozoa into the uterine cavity

Source page: https://510kreport.com/device/K023383
Methodology: https://510kreport.com/methodology