# K910577: Edwards-Wallace Bourne Hall Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Marlo Surgical Technology
- Decided: May 9, 1991 after 87 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972823: Mini-Embryon Intra Uterine Insemination Catheter (1997), 4 descendants of its own
- K982628: Medworks Insemination Catheter (1998), 1 descendant of its own
- K021438: Insemination Catheter, Model 320301 (2002), 0 descendants of its own
- K984306: `the Inseminator' (Proposed) (1999), 0 descendants of its own
- K982630: Medworks Visualization Insemination Catheter (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K910577
Methodology: https://510kreport.com/methodology