Product code HDR
- Device name
- Cap, Cervical
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5250
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025-04-02 |
| K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | 2023-06-23 |
| K993953 | OVES CERVICAL CAP | Veos , Ltd. | 2000-03-21 |
| K945131 | IMAGYN INTRAUTERINE INSEMINATION DEVICE | Imagyn Medical, Inc. | 1995-05-15 |
| K950714 | COOK INSEMINATION CUP | Cook Urological, Inc. | 1995-05-11 |
| K902171 | MINISPACE(TM) IUI CATHETER | Pharmacia, Inc. | 1990-10-05 |
| K902694 | COAXIAL CATHETER SET | Cook Ob/Gyn | 1990-08-28 |
| K896960 | INTRAUTERINE INSEMINATION CATHETERS | C.R. Bard, Inc. | 1990-06-26 |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | Irvine Scientific | 1990-04-16 |
| K900308 | SPERM SELECT SYSTEM | Pharmacia, Inc. | 1990-04-13 |
| K900162 | DGH A-SAN PROBE HOLDER | Jedmed Instrument Co. | 1990-02-16 |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | Irvine Scientific | 1989-09-22 |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | Irvine Scientific | 1989-09-22 |
| K894264 | KDF-2.3 | Unimar, Inc. | 1989-08-15 |
| K890301 | SHEPARD INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | 1989-03-31 |
| K884696 | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET | Laboratoire Ccd C/O Washington Regulatory Services | 1989-01-27 |
| K881414 | CERVICATH | Epcom Medical Systems, Inc. | 1988-06-14 |
| K874668 | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | Irvine Scientific | 1988-03-31 |
| K872849 | SPERM-SELECT ADDITIONAL INDICATION | Pharmacia, Inc. | 1987-09-28 |
| K872088 | FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) | Irvine Scientific | 1987-08-14 |
| K872203 | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | Irvine Scientific | 1987-08-14 |
| K872102 | SPERM WASHING MEDIUM #9932 | Irvine Scientific | 1987-07-16 |
| K871577 | HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES | Irvine Scientific | 1987-07-15 |
| K870551 | INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | 1987-03-02 |
| K861188 | SPERM CAPACITATION MEDIUM | Irvine Scientific | 1987-01-06 |
| K863785 | MAKLER CATHETER | I M, Inc. | 1986-12-11 |
| K861305 | INTRAUTERINE CATHETER | Ram Development | 1986-12-11 |
| K831669 | AXCAN SPERM CUP | Axcan Scientific Corp. | 1983-07-12 |
| K810697 | AXISONIC II | Teknar, Inc. | 1981-07-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810028774124 | Frida Fertility | Fridababy, LLC | 2023-12-05 |
| 03700111400559 | STANDARD INTRA UTERINE INSIMINATION CANNULA | LABORATOIRE CCD | 2023-12-05 |
| 03700111400542 | SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULA | LABORATOIRE CCD | 2023-12-05 |
| 00827002164529 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00827002189034 | Insemi-Form | COOK INCORPORATED | 2016-09-24 |
| 00827002164697 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00827002164680 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00827002164635 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00827002164536 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00827002164543 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00827002164642 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00827002164581 | Shepard | COOK INCORPORATED | 2016-09-24 |
| 00893727002958 | Modified Ham's F-10 Basal Medium | FUJIFILM IRVINE SCIENTIFIC, INC. | 2016-09-10 |
| 00893727002866 | Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin | FUJIFILM IRVINE SCIENTIFIC, INC. | 2016-09-10 |
| 00888937000559 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000603 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000597 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000580 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000573 | Pro-Ceprion Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000566 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000450 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000542 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000535 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000528 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000511 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000504 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000498 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000481 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000474 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |
| 00888937000467 | Pro-Ception Oligospermia Cup | Coopersurgical, Inc. | 2016-03-28 |