HTF Medium and Modified HTF Medium-Hepes
FDA 510(k) K871577 · Irvine Scientific
510(k) numberK871577
Submission
- Device name
- HTF Medium and Modified HTF Medium-Hepes
- Applicant
- Irvine Scientific
Santa Ana, CA, US - Received
- April 23, 1987
- Decision date
- July 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDR – Cap, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Specialty
- Obstetrics/Gynecology
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| K945131 | Imagyn Intrauterine Insemination DeviceHDR · Traditional | Imagyn Medical, Inc. | 05/15/1995SE |
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| K902171 | Minispace(Tm) Iui CatheterHDR · Traditional | Pharmacia, Inc. | 10/05/1990SE |
| K902694 | Coaxial Catheter SetHDR · Traditional | Cook Ob/Gyn | 08/28/1990SE |
| K896960 | Intrauterine Insemination CathetersHDR · Traditional | C.R. Bard, Inc. | 06/26/1990SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | Irvine Scientific | 04/16/1990SE |
| K900308 | Sperm Select SystemHDR · Traditional | Pharmacia, Inc. | 04/13/1990SE |
More from Pharmacia, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…MQL · Traditional | 05/04/2016SE |
| K914541 | Sperm Maintenance Medium with GlycerolMFD · Traditional | 02/03/1994SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | 04/16/1990SE |
| K894432 | Modified Ham's F-10 W/AlbuminHDR · Traditional | 09/22/1989SE |
| K894405 | HTF with Albumin (Catalog No. 9994)HDR · Traditional | 09/22/1989SE |
| K874668 | Sperm Washing Medium #9983 & Modified #9984HDR · Traditional | 03/31/1988SE |
| K872203 | Cat. #9972 Refrigeration Medium (Test Yolk Buffer)HDR · Traditional | 08/14/1987SE |
| K872088 | Freezing Medium (Test Yolk Buffer W/Glycerol)HDR · Traditional | 08/14/1987SE |
| K872102 | Sperm Washing Medium #9932HDR · Traditional | 07/16/1987SE |
| K861188 | Sperm Capacitation MediumHDR · Traditional | 01/06/1987SE |
Questions and answers
When was HTF Medium and Modified HTF Medium-Hepes cleared by the FDA?
HTF Medium and Modified HTF Medium-Hepes (K871577) received a 510(k) decision of Substantially Equivalent on July 15, 1987, 83 days after the submission was received.
What is the product code of K871577?
The FDA product code is HDR – Cap, Cervical, a Class II (moderate risk) device regulated under 21 CFR 884.5250.