Cap, Cervical
FDA product code HDR · Class II (moderate risk) · 21 CFR 884.5250 · Obstetrics/Gynecology
29510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Irvine Scientific 9
- Cook Ob/Gyn 3
- Pharmacia, Inc. 3
- Laboratoire Ccd C/O Washington Regulatory Services 1
- Stepone Fertility Ltd (T/A Béa Fertility) 1
- Rosesta Medical BV 1
- Veos , Ltd. 1
- Imagyn Medical, Inc. 1
- Cook Urological, Inc. 1
- C.R. Bard, Inc. 1
- Jedmed Instrument Co. 1
- Unimar, Inc. 1
- Teknar, Inc. 1
- Epcom Medical Systems, Inc. 1
- I M, Inc. 1
- Ram Development 1
- Axcan Scientific Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01)HDR · Traditional | Stepone Fertility Ltd (T/A Béa Fertility) | 04/02/2025SE |
| K222969 | FERTI-LILY Conception CupHDR · Traditional | Rosesta Medical BV | 06/23/2023SE |
| K993953 | Oves Cervical CapHDR · Traditional | Veos , Ltd. | 03/21/2000SESU |
| K945131 | Imagyn Intrauterine Insemination DeviceHDR · Traditional | Imagyn Medical, Inc. | 05/15/1995SE |
| K950714 | Cook Insemination CupHDR · Traditional | Cook Urological, Inc. | 05/11/1995SE |
| 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 |
| K900162 | DGH A-San Probe HolderHDR · Traditional | Jedmed Instrument Co. | 02/16/1990SE |
| K894432 | Modified Ham's F-10 W/AlbuminHDR · Traditional | Irvine Scientific | 09/22/1989SE |
| K894405 | HTF with Albumin (Catalog No. 9994)HDR · Traditional | Irvine Scientific | 09/22/1989SE |
| K894264 | KDF-2.3HDR · Traditional | Unimar, Inc. | 08/15/1989SE |
| K890301 | Shepard Intrauterine Insemination CatheterHDR · Traditional | Cook Ob/Gyn | 03/31/1989SE |
| K884696 | Resubmitted Artificial Insemination Instrument SetHDR · Traditional | Laboratoire Ccd C/O Washington Regulatory Services | 01/27/1989SE |
| K881414 | CervicathHDR · Traditional | Epcom Medical Systems, Inc. | 06/14/1988SE |
| K874668 | Sperm Washing Medium #9983 & Modified #9984HDR · Traditional | Irvine Scientific | 03/31/1988SE |
| K872849 | Sperm-Select Additional IndicationHDR · Traditional | Pharmacia, Inc. | 09/28/1987SE |
| K872203 | Cat. #9972 Refrigeration Medium (Test Yolk Buffer)HDR · Traditional | Irvine Scientific | 08/14/1987SE |
| K872088 | Freezing Medium (Test Yolk Buffer W/Glycerol)HDR · Traditional | Irvine Scientific | 08/14/1987SE |
| K872102 | Sperm Washing Medium #9932HDR · Traditional | Irvine Scientific | 07/16/1987SE |
| K871577 | HTF Medium and Modified HTF Medium-HepesHDR · Traditional | Irvine Scientific | 07/15/1987SE |
| K870551 | Intrauterine Insemination CatheterHDR · Traditional | Cook Ob/Gyn | 03/02/1987SE |
| K861188 | Sperm Capacitation MediumHDR · Traditional | Irvine Scientific | 01/06/1987SE |
| K863785 | Makler CatheterHDR · Traditional | I M, Inc. | 12/11/1986SE |
| K861305 | Intrauterine CatheterHDR · Traditional | Ram Development | 12/11/1986SE |
| K831669 | Axcan Sperm CupHDR · Traditional | Axcan Scientific Corp. | 07/12/1983SE |
| K810697 | Axisonic IIHDR · Traditional | Teknar, Inc. | 07/13/1981SE |