# K970750: Microspan Insemination System

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical, Inc.
- Decided: May 5, 1997 after 63 days
- Product code: MFD (Cannula, Intrauterine Insemination)
- Device class: 2
- Regulation: 21 CFR 884.5250
- 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 FDA summary names its predicate without a number.
- (no number) Imagyn Intrauterine Insemination Device: named in the summary without a submission number
- (no number) Cook OB/GYN Coaxial Catheter Set: named in the summary without a submission number
- (no number) Cook OB/GYN Shepard Intrauterine Insemination Catheter: named in the summary without a submission number
- (no number) Cook OB/GYN Jansen-Anderson Insemination Set: named in the summary without a submission number
- (no number) Cook OB/GYN Spirtos Coaxial Catheter Set: named in the summary without a submission number

## Most influential descendants
- K982630: Medworks Visualization Insemination Catheter (1999), 0 descendants of its own

## Indications for use
Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer’s solution.

Source page: https://510kreport.com/device/K970750
Methodology: https://510kreport.com/methodology