Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5250](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5250) → MFD — Cannula, Intrauterine Insemination # MFD · Cannula, Intrauterine Insemination _Obstetrics/Gynecology · 21 CFR 884.5250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD ## Overview - **Product Code:** MFD - **Device Name:** Cannula, Intrauterine Insemination - **Regulation:** [21 CFR 884.5250](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5250) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) ## 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K021438.md) | INSEMINATION CATHETER, MODEL 320301 | Labotect Labor-Technik Gottingen | Jul 16, 2002 | SESE | | [K012935](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K012935.md) | THECURVE, ITEM 507 | Select Medical Systems, Inc. | Oct 11, 2001 | SESE | | [K984306](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K984306.md) | `THE INSEMINATOR' (PROPOSED) | Wallach Surgical Devices, Inc. | Mar 1, 1999 | SESE | | [K982630](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K982630.md) | MEDWORKS VISUALIZATION INSEMINATION CATHETER | Medworks Corp. | Jan 14, 1999 | SESE | | [K982628](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K982628.md) | MEDWORKS INSEMINATION CATHETER | Medworks Corp. | Aug 21, 1998 | SESE | | [K980061](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K980061.md) | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER | Rocket Medical Plc | Mar 2, 1998 | SESE | | [K972823](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K972823.md) | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | A & A Medical, Inc. | Oct 10, 1997 | SESE | | [K972245](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K972245.md) | TOM CAT F.L., TOM CAT S.L. | A & A Medical, Inc. | Aug 6, 1997 | SESE | | [K970750](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K970750.md) | MICROSPAN INSEMINATION SYSTEM | Imagyn Medical, Inc. | May 5, 1997 | SESE | | [K964848](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K964848.md) | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | Marlow Surgical Technologies, Inc. | Jan 16, 1997 | SESE | | [K963031](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K963031.md) | GENXCATHETER | Genx Intl., Inc. | Oct 21, 1996 | SESE | | [K962273](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K962273.md) | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Marlo Surgical Technology | Jul 31, 1996 | SESE | | [K940176](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K940176.md) | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Ackrad Laboratories | Apr 23, 1996 | SESE | | [K954398](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K954398.md) | INSEMI-CATH II | Cook Urological, Inc. | Dec 19, 1995 | SESE | | [K954099](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K954099.md) | SELECT IUI | Select Medical Systems, Inc. | Nov 22, 1995 | SESE | | [K953719](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K953719.md) | HUMAN TUBAL FLUID | Life Technologies, Inc. | Nov 6, 1995 | SESE | | [K951835](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K951835.md) | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE | Life Technologies, Inc. | Aug 11, 1995 | SESE | | [K932993](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K932993.md) | INTRAUTERINE CATHETER AND INTRODUCER | Conceptus, Inc. | Jan 6, 1995 | SESE | | [K921518](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K921518.md) | LIFETEK IUI CATHETER | Lifetek Medical, Inc. | May 10, 1994 | SESE | | [K931630](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD/K931630.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/MFD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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