Modified F-10 Culture Medium W/O Hypoxanthine
FDA 510(k) K923612 · Life-Tech Intl., Inc.
510(k) numberK923612
Submission
- Device name
- Modified F-10 Culture Medium W/O Hypoxanthine
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- July 21, 1992
- Decision date
- September 7, 1993
- 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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| K982630 | Medworks Visualization Insemination CatheterMFD · Traditional | Medworks Corp. | 01/14/1999SE |
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| 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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| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
Questions and answers
When was Modified F-10 Culture Medium W/O Hypoxanthine cleared by the FDA?
Modified F-10 Culture Medium W/O Hypoxanthine (K923612) received a 510(k) decision of Substantially Equivalent on September 7, 1993, 413 days after the submission was received.
What is the product code of K923612?
The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.