HDR — Cap, Cervical Class II
FDA product code HDR covers "Cap, Cervical", a Class II medical device regulated under 21 CFR 884.5250. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HDR
- Device Class
- Class II
- Regulation Number
- 884.5250
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242031 | stepone fertility ltd (t/a béa fertility) | Béa Applicator (BAP-GB-01) | April 2, 2025 |
| K222969 | rosesta medical | FERTI-LILY Conception Cup | June 23, 2023 |
| K993953 | veos | OVES CERVICAL CAP | March 21, 2000 |
| K945131 | imagyn medical | IMAGYN INTRAUTERINE INSEMINATION DEVICE | May 15, 1995 |
| K950714 | cook urological | COOK INSEMINATION CUP | May 11, 1995 |
| K902171 | pharmacia | MINISPACE(TM) IUI CATHETER | October 5, 1990 |
| K902694 | cook ob/gyn | COAXIAL CATHETER SET | August 28, 1990 |
| K896960 | c.r. bard | INTRAUTERINE INSEMINATION CATHETERS | June 26, 1990 |
| K900316 | irvine scientific | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | April 16, 1990 |
| K900308 | pharmacia | SPERM SELECT SYSTEM | April 13, 1990 |
| K900162 | jedmed instrument | DGH A-SAN PROBE HOLDER | February 16, 1990 |
| K894405 | irvine scientific | HTF WITH ALBUMIN (CATALOG NO. 9994) | September 22, 1989 |
| K894432 | irvine scientific | MODIFIED HAM'S F-10 W/ALBUMIN | September 22, 1989 |
| K894264 | unimar | KDF-2.3 | August 15, 1989 |
| K890301 | cook ob/gyn | SHEPARD INTRAUTERINE INSEMINATION CATHETER | March 31, 1989 |
| K884696 | laboratoire ccd c/o washington regulatory services | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET | January 27, 1989 |
| K881414 | epcom medical systems | CERVICATH | June 14, 1988 |
| K874668 | irvine scientific | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | March 31, 1988 |
| K872849 | pharmacia | SPERM-SELECT ADDITIONAL INDICATION | September 28, 1987 |
| K872203 | irvine scientific | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | August 14, 1987 |