Cannula, Intrauterine Insemination
The intrauterine insemination cannula is an obstetrics/gynecology device used to transcervically deliver processed sperm directly into the uterine cavity during assisted reproduction procedures, including intrauterine insemination for the treatment of infertility. It is classified as FDA Class II under 21 CFR 884.5250 within the Obstetrics/Gynecology specialty, requiring 510(k) premarket clearance. The product code is MFD and the device is not implanted. Full GMP compliance is required.
Research product code MFD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MFD
- Device Class
- FDA class 2
- Regulation Number
- 884.5250
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 29 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K021438 | INSEMINATION CATHETER, MODEL 320301 | Jul 16, 2002 | Substantially Equivalent | Labotect Labor-Technik Gottingen |
| K012935 | THECURVE, ITEM 507 | Oct 11, 2001 | Substantially Equivalent | Select Medical Systems, Inc. |
| K984306 | `THE INSEMINATOR' (PROPOSED) | Mar 01, 1999 | Substantially Equivalent | Wallach Surgical Devices, Inc. |
| K982630 | MEDWORKS VISUALIZATION INSEMINATION CATHETER | Jan 14, 1999 | Substantially Equivalent | Medworks Corp. |
| K982628 | MEDWORKS INSEMINATION CATHETER | Aug 21, 1998 | Substantially Equivalent | Medworks Corp. |
| K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER | Mar 02, 1998 | Substantially Equivalent | Rocket Medical Plc |
| K972823 | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | Oct 10, 1997 | Substantially Equivalent | A & A Medical, Inc. |
| K972245 | TOM CAT F.L., TOM CAT S.L. | Aug 06, 1997 | Substantially Equivalent | A & A Medical, Inc. |
| K970750 | MICROSPAN INSEMINATION SYSTEM | May 05, 1997 | Substantially Equivalent | Imagyn Medical, Inc. |
| K964848 | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | Jan 16, 1997 | Substantially Equivalent | Marlow Surgical Technologies, Inc. |
| K963031 | GENXCATHETER | Oct 21, 1996 | Substantially Equivalent | Genx Intl., Inc. |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Jul 31, 1996 | Substantially Equivalent | Marlo Surgical Technology |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Apr 23, 1996 | Substantially Equivalent | Ackrad Laboratories |
| K954398 | INSEMI-CATH II | Dec 19, 1995 | Substantially Equivalent | Cook Urological, Inc. |
| K954099 | SELECT IUI | Nov 22, 1995 | Substantially Equivalent | Select Medical Systems, Inc. |
| K953719 | HUMAN TUBAL FLUID | Nov 06, 1995 | Substantially Equivalent | Life Technologies, Inc. |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE | Aug 11, 1995 | Substantially Equivalent | Life Technologies, Inc. |
| K932993 | INTRAUTERINE CATHETER AND INTRODUCER | Jan 06, 1995 | Substantially Equivalent | Conceptus, Inc. |
| K921518 | LIFETEK IUI CATHETER | May 10, 1994 | Substantially Equivalent | Lifetek Medical, Inc. |
| K931630 | INSEMI-CATH | Apr 19, 1994 | Substantially Equivalent | Cook Ob/Gyn |
| K914541 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | Feb 03, 1994 | Substantially Equivalent | Irvine Scientific |
| K923652 | DULBECCO'S PHOSPHATE BUFFERED SALINE | Sep 07, 1993 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K923651 | DISTILLED WATER | Sep 07, 1993 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K923634 | MODIFIED F-10 CULTURE MEDIUM | Sep 07, 1993 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K923612 | MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE | Sep 07, 1993 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K914150 | JANSEN-ANDERSON INSEMINATION SET | Sep 02, 1992 | Substantially Equivalent | Cook Ob/Gyn |
| K910577 | EDWARDS-WALLACE BOURNE HALL CATHETER | May 09, 1991 | Substantially Equivalent | Marlo Surgical Technology |
| K910317 | UNI-SEM(TM) | May 01, 1991 | Substantially Equivalent | Unimar, Inc. |
| K905764 | SEMINOR | Mar 12, 1991 | Substantially Equivalent | Promedex, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.