Product code MFD
- Device name
- Cannula, Intrauterine Insemination
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5250
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021438 | INSEMINATION CATHETER, MODEL 320301 | Labotect Labor-Technik Gottingen | 2002-07-16 |
| K012935 | THECURVE, ITEM 507 | Select Medical Systems, Inc. | 2001-10-11 |
| K984306 | `THE INSEMINATOR' (PROPOSED) | Wallach Surgical Devices, Inc. | 1999-03-01 |
| K982630 | MEDWORKS VISUALIZATION INSEMINATION CATHETER | Medworks Corp. | 1999-01-14 |
| K982628 | MEDWORKS INSEMINATION CATHETER | Medworks Corp. | 1998-08-21 |
| K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER | Rocket Medical Plc | 1998-03-02 |
| K972823 | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | A & A Medical, Inc. | 1997-10-10 |
| K972245 | TOM CAT F.L., TOM CAT S.L. | A & A Medical, Inc. | 1997-08-06 |
| K970750 | MICROSPAN INSEMINATION SYSTEM | Imagyn Medical, Inc. | 1997-05-05 |
| K964848 | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | Marlow Surgical Technologies, Inc. | 1997-01-16 |
| K963031 | GENXCATHETER | Genx Intl., Inc. | 1996-10-21 |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Marlo Surgical Technology | 1996-07-31 |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Ackrad Laboratories | 1996-04-23 |
| K954398 | INSEMI-CATH II | Cook Urological, Inc. | 1995-12-19 |
| K954099 | SELECT IUI | Select Medical Systems, Inc. | 1995-11-22 |
| K953719 | HUMAN TUBAL FLUID | Life Technologies, Inc. | 1995-11-06 |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE | Life Technologies, Inc. | 1995-08-11 |
| K932993 | INTRAUTERINE CATHETER AND INTRODUCER | Conceptus, Inc. | 1995-01-06 |
| K921518 | LIFETEK IUI CATHETER | Lifetek Medical, Inc. | 1994-05-10 |
| K931630 | INSEMI-CATH | Cook Ob/Gyn | 1994-04-19 |
| K914541 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | Irvine Scientific | 1994-02-03 |
| K923652 | DULBECCO'S PHOSPHATE BUFFERED SALINE | Life-Tech Intl., Inc. | 1993-09-07 |
| K923651 | DISTILLED WATER | Life-Tech Intl., Inc. | 1993-09-07 |
| K923634 | MODIFIED F-10 CULTURE MEDIUM | Life-Tech Intl., Inc. | 1993-09-07 |
| K923612 | MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE | Life-Tech Intl., Inc. | 1993-09-07 |
| K914150 | JANSEN-ANDERSON INSEMINATION SET | Cook Ob/Gyn | 1992-09-02 |
| K910577 | EDWARDS-WALLACE BOURNE HALL CATHETER | Marlo Surgical Technology | 1991-05-09 |
| K910317 | UNI-SEM(TM) | Unimar, Inc. | 1991-05-01 |
| K905764 | SEMINOR | Promedex, Inc. | 1991-03-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812261016603 | Insemina Intra Uterine Insemination Catheter | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00819374022491 | Flexi Intra Uterine Insemination Catheter Open Tip | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00819374022019 | Trackable Intra Uterine Insemination Catheter Open Tip | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00819374021890 | Curved Insemina Intra Uterine Insemination Catheter Open Tip | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00819374021814 | Insemina Open Tip Intra Uterine Insemination Catheter | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00812261016863 | Trackable Intra Uterine Insemination Catheter | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00812261016825 | Flexi Intra Uterine Insemination Catheter | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00812261016818 | Curved Intra Uterine Insemination Catheter | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00812261016610 | Stumpy Intra Uterine Insemination Cannula | ALLWIN MEDICAL DEVICES, INC. | 2020-09-18 |
| 00888937021332 | Wallace Artificial Insemination Catheter | Coopersurgical, Inc. | 2019-09-26 |
| 15019315015700 | Wallace | ICU MEDICAL, INC. | 2016-10-05 |
| 00827002169449 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 00827002169616 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 00827002173439 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 00827002189522 | Cook | COOK INCORPORATED | 2016-09-24 |
| 20888937011474 | The Inseminator | Coopersurgical, Inc. | 2016-08-25 |
| 00888937011487 | The Inseminator | Coopersurgical, Inc. | 2016-08-25 |
| 00888937011470 | The Inseminator | Coopersurgical, Inc. | 2016-08-25 |
| 00888937003604 | TheCurve | Coopersurgical, Inc. | 2016-08-09 |
| 00888937003659 | MiniSpace | Coopersurgical, Inc. | 2016-08-09 |
| 00888937003598 | Select IUI | Coopersurgical, Inc. | 2016-08-09 |
| 00888937003468 | Uni-Sem | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003462 | Uni-Sem | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003592 | Select IUI | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003608 | TheCurve | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003653 | MiniSpace | Coopersurgical, Inc. | 2016-08-09 |
| 00888937001228 | Insemination Cannula with Syringe | Coopersurgical, Inc. | 2016-03-21 |
| 20888937001215 | Insemination Cannula with Syringe | Coopersurgical, Inc. | 2016-03-21 |
| 20888937001222 | Insemination Cannula with Syringe | Coopersurgical, Inc. | 2016-03-21 |
| 00888937001211 | Insemination Cannula with Syringe | Coopersurgical, Inc. | 2016-03-21 |