FDA Product Code
FDA Product Code HDR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5250
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025-04-02 | Traditional | PDF ↗ |
| K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | 2023-06-23 | Traditional | PDF ↗ |
| K993953 | OVES CERVICAL CAP | Veos , Ltd. | 2000-03-21 | Traditional | PDF ↗ |
| K945131 | IMAGYN INTRAUTERINE INSEMINATION DEVICE | Imagyn Medical, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K950714 | COOK INSEMINATION CUP | Cook Urological, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K902171 | MINISPACE(TM) IUI CATHETER | Pharmacia, Inc. | 1990-10-05 | Traditional | PDF ↗ |
| K902694 | COAXIAL CATHETER SET | Cook Ob/Gyn | 1990-08-28 | Traditional | PDF ↗ |
| K896960 | INTRAUTERINE INSEMINATION CATHETERS | C.R. Bard, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | Irvine Scientific | 1990-04-16 | Traditional | PDF ↗ |
| K900308 | SPERM SELECT SYSTEM | Pharmacia, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K900162 | DGH A-SAN PROBE HOLDER | Jedmed Instrument Co. | 1990-02-16 | Traditional | PDF ↗ |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | Irvine Scientific | 1989-09-22 | Traditional | PDF ↗ |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | Irvine Scientific | 1989-09-22 | Traditional | PDF ↗ |
| K894264 | KDF-2.3 | Unimar, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K890301 | SHEPARD INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | 1989-03-31 | Traditional | PDF ↗ |
| K884696 | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET | Laboratoire Ccd C/O Washington Regulatory Services | 1989-01-27 | Traditional | PDF ↗ |
| K881414 | CERVICATH | Epcom Medical Systems, Inc. | 1988-06-14 | Traditional | PDF ↗ |
| K874668 | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | Irvine Scientific | 1988-03-31 | Traditional | PDF ↗ |
| K872849 | SPERM-SELECT ADDITIONAL INDICATION | Pharmacia, Inc. | 1987-09-28 | Traditional | PDF ↗ |
| K872088 | FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) | Irvine Scientific | 1987-08-14 | Traditional | PDF ↗ |
| K872203 | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | Irvine Scientific | 1987-08-14 | Traditional | PDF ↗ |
| K872102 | SPERM WASHING MEDIUM #9932 | Irvine Scientific | 1987-07-16 | Traditional | PDF ↗ |
| K871577 | HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES | Irvine Scientific | 1987-07-15 | Traditional | PDF ↗ |
| K870551 | INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | 1987-03-02 | Traditional | PDF ↗ |
| K861188 | SPERM CAPACITATION MEDIUM | Irvine Scientific | 1987-01-06 | Traditional | PDF ↗ |
| K861305 | INTRAUTERINE CATHETER | Ram Development | 1986-12-11 | Traditional | PDF ↗ |
| K863785 | MAKLER CATHETER | I M, Inc. | 1986-12-11 | Traditional | PDF ↗ |
| K831669 | AXCAN SPERM CUP | Axcan Scientific Corp. | 1983-07-12 | Traditional | PDF ↗ |
| K810697 | AXISONIC II | Teknar, Inc. | 1981-07-13 | Traditional | PDF ↗ |
Product code HDR · Class II · Obstetrics/Gynecology. Data: openFDA.