FDA Product Code
FDA Product Code MFD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5250
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K021438 | INSEMINATION CATHETER, MODEL 320301 | Labotect Labor-Technik Gottingen | 2002-07-16 | Abbreviated | PDF ↗ |
| K012935 | THECURVE, ITEM 507 | Select Medical Systems, Inc. | 2001-10-11 | Traditional | PDF ↗ |
| K984306 | `THE INSEMINATOR' (PROPOSED) | Wallach Surgical Devices, Inc. | 1999-03-01 | Traditional | PDF ↗ |
| K982630 | MEDWORKS VISUALIZATION INSEMINATION CATHETER | Medworks Corp. | 1999-01-14 | Traditional | PDF ↗ |
| K982628 | MEDWORKS INSEMINATION CATHETER | Medworks Corp. | 1998-08-21 | Traditional | PDF ↗ |
| K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER | Rocket Medical Plc | 1998-03-02 | Traditional | PDF ↗ |
| K972823 | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | A & A Medical, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K972245 | TOM CAT F.L., TOM CAT S.L. | A & A Medical, Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K970750 | MICROSPAN INSEMINATION SYSTEM | Imagyn Medical, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K964848 | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | Marlow Surgical Technologies, Inc. | 1997-01-16 | Traditional | PDF ↗ |
| K963031 | GENXCATHETER | Genx Intl., Inc. | 1996-10-21 | Traditional | PDF ↗ |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Marlo Surgical Technology | 1996-07-31 | Traditional | PDF ↗ |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Ackrad Laboratories | 1996-04-23 | Traditional | PDF ↗ |
| K954398 | INSEMI-CATH II | Cook Urological, Inc. | 1995-12-19 | Traditional | PDF ↗ |
| K954099 | SELECT IUI | Select Medical Systems, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K953719 | HUMAN TUBAL FLUID | Life Technologies, Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE | Life Technologies, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K932993 | INTRAUTERINE CATHETER AND INTRODUCER | Conceptus, Inc. | 1995-01-06 | Traditional | PDF ↗ |
| K921518 | LIFETEK IUI CATHETER | Lifetek Medical, Inc. | 1994-05-10 | Traditional | PDF ↗ |
| K931630 | INSEMI-CATH | Cook Ob/Gyn | 1994-04-19 | Traditional | PDF ↗ |
| K914541 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | Irvine Scientific | 1994-02-03 | Traditional | PDF ↗ |
| K923651 | DISTILLED WATER | Life-Tech Intl., Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K923634 | MODIFIED F-10 CULTURE MEDIUM | Life-Tech Intl., Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K923652 | DULBECCO'S PHOSPHATE BUFFERED SALINE | Life-Tech Intl., Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K923612 | MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE | Life-Tech Intl., Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K914150 | JANSEN-ANDERSON INSEMINATION SET | Cook Ob/Gyn | 1992-09-02 | Traditional | PDF ↗ |
| K910577 | EDWARDS-WALLACE BOURNE HALL CATHETER | Marlo Surgical Technology | 1991-05-09 | Traditional | PDF ↗ |
| K910317 | UNI-SEM(TM) | Unimar, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K905764 | SEMINOR | Promedex, Inc. | 1991-03-12 | Traditional | PDF ↗ |
Product code MFD · Class II · Obstetrics/Gynecology. Data: openFDA.