MFD · Cannula, Intrauterine Insemination
Obstetrics/Gynecology · 21 CFR 884.5250 · Class 2
Overview
| Product Code | MFD |
|---|---|
| Device Name | Cannula, Intrauterine Insemination |
| Regulation | 21 CFR 884.5250 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K021438 | INSEMINATION CATHETER, MODEL 320301 | Labotect Labor-Technik Gottingen | Jul 16, 2002 | SESE |
| K012935 | THECURVE, ITEM 507 | Select Medical Systems, Inc. | Oct 11, 2001 | SESE |
| K984306 | `THE INSEMINATOR' (PROPOSED) | Wallach Surgical Devices, Inc. | Mar 1, 1999 | SESE |
| K982630 | MEDWORKS VISUALIZATION INSEMINATION CATHETER | Medworks Corp. | Jan 14, 1999 | SESE |
| K982628 | MEDWORKS INSEMINATION CATHETER | Medworks Corp. | Aug 21, 1998 | SESE |
| K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER | Rocket Medical Plc | Mar 2, 1998 | SESE |
| K972823 | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | A & A Medical, Inc. | Oct 10, 1997 | SESE |
| K972245 | TOM CAT F.L., TOM CAT S.L. | A & A Medical, Inc. | Aug 6, 1997 | SESE |
| K970750 | MICROSPAN INSEMINATION SYSTEM | Imagyn Medical, Inc. | May 5, 1997 | SESE |
| K964848 | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | Marlow Surgical Technologies, Inc. | Jan 16, 1997 | SESE |
| K963031 | GENXCATHETER | Genx Intl., Inc. | Oct 21, 1996 | SESE |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Marlo Surgical Technology | Jul 31, 1996 | SESE |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Ackrad Laboratories | Apr 23, 1996 | SESE |
| K954398 | INSEMI-CATH II | Cook Urological, Inc. | Dec 19, 1995 | SESE |
| K954099 | SELECT IUI | Select Medical Systems, Inc. | Nov 22, 1995 | SESE |
| K953719 | HUMAN TUBAL FLUID | Life Technologies, Inc. | Nov 6, 1995 | SESE |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE | Life Technologies, Inc. | Aug 11, 1995 | SESE |
| K932993 | INTRAUTERINE CATHETER AND INTRODUCER | Conceptus, Inc. | Jan 6, 1995 | SESE |
| K921518 | LIFETEK IUI CATHETER | Lifetek Medical, Inc. | May 10, 1994 | SESE |
| K931630 | INSEMI-CATH | Cook Ob/Gyn | Apr 19, 1994 | SESE |
Top Applicants
- Life-Tech Intl., Inc. — 4 clearances
- A & A Medical, Inc. — 2 clearances
- Cook Ob/Gyn — 2 clearances
- Life Technologies, Inc. — 2 clearances
- Marlo Surgical Technology — 2 clearances
