Insemi-Cath II
FDA 510(k) K954398 · Cook Urological, Inc.
510(k) numberK954398
Submission
- Device name
- Insemi-Cath II
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- September 20, 1995
- Decision date
- December 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MFD – Cannula, Intrauterine Insemination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K021438 | Insemination Catheter, Model 320301MFD · Abbreviated | Labotect Labor-Technik Gottingen | 07/16/2002SE |
| K012935 | Thecurve, Item 507MFD · Traditional | Select Medical Systems, Inc. | 10/11/2001SE |
| K984306 | `The Inseminator' (Proposed)MFD · Traditional | Wallach Surgical Devices, Inc. | 03/01/1999SE |
| K982630 | Medworks Visualization Insemination CatheterMFD · Traditional | Medworks Corp. | 01/14/1999SE |
| K982628 | Medworks Insemination CatheterMFD · Traditional | Medworks Corp. | 08/21/1998SE |
| K980061 | Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination…MFD · Traditional | Rocket Medical Plc | 03/02/1998SE |
| K972823 | Mini-Embryon Intra Uterine Insemination CatheterMFD · Traditional | A & A Medical, Inc. | 10/10/1997SE |
| K972245 | Tom Cat F.L., Tom Cat S.L.MFD · Traditional | A & A Medical, Inc. | 08/06/1997SE |
| K970750 | Microspan Insemination SystemMFD · Traditional | Imagyn Medical, Inc. | 05/05/1997SE |
| K964848 | Wallace Artificial Insemination Catheter - 8CM/18CMMFD · Traditional | Marlow Surgical Technologies, Inc. | 01/16/1997SE |
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|---|---|---|
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| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
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| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
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Questions and answers
When was Insemi-Cath II cleared by the FDA?
Insemi-Cath II (K954398) received a 510(k) decision of Substantially Equivalent on December 19, 1995, 90 days after the submission was received.
What is the product code of K954398?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.