MFD — Cannula, Intrauterine Insemination Class II
FDA product code MFD covers "Cannula, Intrauterine Insemination", a Class II medical device regulated under 21 CFR 884.5250. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MFD
- Device Class
- Class II
- Regulation Number
- 884.5250
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K021438 | labotect labor-technik gottingen | INSEMINATION CATHETER, MODEL 320301 | July 16, 2002 |
| K012935 | select medical systems | THECURVE, ITEM 507 | October 11, 2001 |
| K984306 | wallach surgical devices | `THE INSEMINATOR' (PROPOSED) | March 1, 1999 |
| K982630 | medworks | MEDWORKS VISUALIZATION INSEMINATION CATHETER | January 14, 1999 |
| K982628 | medworks | MEDWORKS INSEMINATION CATHETER | August 21, 1998 |
| K980061 | rocket medical | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATIO | March 2, 1998 |
| K972823 | a and a medical | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | October 10, 1997 |
| K972245 | a and a medical | TOM CAT F.L., TOM CAT S.L. | August 6, 1997 |
| K970750 | imagyn medical | MICROSPAN INSEMINATION SYSTEM | May 5, 1997 |
| K964848 | marlow surgical technologies | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | January 16, 1997 |
| K963031 | genx intl | GENXCATHETER | October 21, 1996 |
| K962273 | marlo surgical technology | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | July 31, 1996 |
| K940176 | ackrad laboratories | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | April 23, 1996 |
| K954398 | cook urological | INSEMI-CATH II | December 19, 1995 |
| K954099 | select medical systems | SELECT IUI | November 22, 1995 |
| K953719 | life technologies | HUMAN TUBAL FLUID | November 6, 1995 |
| K951835 | life technologies | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT | August 11, 1995 |
| K932993 | conceptus | INTRAUTERINE CATHETER AND INTRODUCER | January 6, 1995 |
| K921518 | lifetek medical | LIFETEK IUI CATHETER | May 10, 1994 |
| K931630 | cook ob/gyn | INSEMI-CATH | April 19, 1994 |