# K982630: Medworks Visualization Insemination Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medworks Corp.
- Decided: Jan 14, 1999 after 170 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
Longest line of descent: 2 generations back to K910577 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884696: Resubmitted Artificial Insemination Instrument Set, Laboratoire Ccd C/O Washington Regulatory Services (1989) Summary page 1.
- K972823: Mini-Embryon Intra Uterine Insemination Catheter, A & A Medical, Inc. (1997) Summary page 1.
- K914150: Jansen-Anderson Insemination Set, Cook Ob/Gyn (1992) Summary page 1.
- K897100: Centurion Vaginal Speculum, Tri-State Hospital Supply Corp. (1990) Summary page 1.
- K981928: Galileo Disposable Endoscopes, Galileo Electro-Optics Corp. (1998). Cleared while this submission was under review Summary page 1.
- K970750: Microspan Insemination System, Imagyn Medical, Inc. (1997) Summary page 1.
- K961506: Microspan Hysteroscope Sheath, Imagyn Medical, Inc. (1996) Summary page 1.
- K961688: Microspan Hysteroscope, Imagyn Medical, Inc. (1996) Summary page 1.

## Indications for use
For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Source page: https://510kreport.com/device/K982630
Methodology: https://510kreport.com/methodology