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 |
|---|---|---|---|
| 30888937021333 | Wallace Artificial Insemination Catheter | Coopersurgical, Inc. | 2019-09-26 |
| 35019315071533 | Pneupac | Smiths Medical International Ltd | 2017-01-03 |
| 35019315015704 | Wallace | Smiths Medical International Ltd | 2016-10-05 |
| 00827002537446 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 00827002303997 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 00827002266155 | Pivet | COOK INCORPORATED | 2016-09-24 |
| 00827002191297 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 00827002190849 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 10827002189536 | Cook | COOK INCORPORATED | 2016-09-24 |
| 10827002189529 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002181908 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 00827002181830 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 00827002179127 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 10827002173436 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 10827002169613 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 10827002169446 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 10827002167862 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 10827002167077 | Insemi-Cath | COOK INCORPORATED | 2016-09-24 |
| 00827002537453 | Soft-Pass | COOK INCORPORATED | 2016-09-24 |
| 00724995095376 | Quick Connect | Corporation Steris Canada | 2016-09-13 |
| 00888937011494 | The Inseminator | Coopersurgical, Inc. | 2016-08-25 |
| 20888937011481 | The Inseminator | Coopersurgical, Inc. | 2016-08-25 |
| 20888937011474 | The Inseminator | Coopersurgical, Inc. | 2016-08-25 |
| 60888937003644 | SpermSelect Curve Kit | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003653 | MiniSpace | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003608 | TheCurve | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003592 | Select IUI | Coopersurgical, Inc. | 2016-08-09 |
| 20888937003462 | Uni-Sem | Coopersurgical, Inc. | 2016-08-09 |
| 20888937001222 | Insemination Cannula with Syringe | Coopersurgical, Inc. | 2016-03-21 |
| 20888937001215 | Insemination Cannula with Syringe | Coopersurgical, Inc. | 2016-03-21 |