HDR · Cap, Cervical
Obstetrics/Gynecology · 21 CFR 884.5250 · Class 2
Overview
| Product Code | HDR |
|---|---|
| Device Name | Cap, Cervical |
| Regulation | 21 CFR 884.5250 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | Apr 2, 2025 | SESE |
| K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | Jun 23, 2023 | SESE |
| K993953 | OVES CERVICAL CAP | Veos , Ltd. | Mar 21, 2000 | SESU |
| K945131 | IMAGYN INTRAUTERINE INSEMINATION DEVICE | Imagyn Medical, Inc. | May 15, 1995 | SESE |
| K950714 | COOK INSEMINATION CUP | Cook Urological, Inc. | May 11, 1995 | SESE |
| K902171 | MINISPACE(TM) IUI CATHETER | Pharmacia, Inc. | Oct 5, 1990 | SESE |
| K902694 | COAXIAL CATHETER SET | Cook Ob/Gyn | Aug 28, 1990 | SESE |
| K896960 | INTRAUTERINE INSEMINATION CATHETERS | C.R. Bard, Inc. | Jun 26, 1990 | SESE |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | Irvine Scientific | Apr 16, 1990 | SESE |
| K900308 | SPERM SELECT SYSTEM | Pharmacia, Inc. | Apr 13, 1990 | SESE |
| K900162 | DGH A-SAN PROBE HOLDER | Jedmed Instrument Co. | Feb 16, 1990 | SESE |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | Irvine Scientific | Sep 22, 1989 | SESE |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | Irvine Scientific | Sep 22, 1989 | SESE |
| K894264 | KDF-2.3 | Unimar, Inc. | Aug 15, 1989 | SESE |
| K890301 | SHEPARD INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | Mar 31, 1989 | SESE |
| K884696 | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET | Laboratoire Ccd C/O Washington Regulatory Services | Jan 27, 1989 | SESE |
| K881414 | CERVICATH | Epcom Medical Systems, Inc. | Jun 14, 1988 | SESE |
| K874668 | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | Irvine Scientific | Mar 31, 1988 | SESE |
| K872849 | SPERM-SELECT ADDITIONAL INDICATION | Pharmacia, Inc. | Sep 28, 1987 | SESE |
| K872203 | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | Irvine Scientific | Aug 14, 1987 | SESE |
Top Applicants
- Irvine Scientific — 9 clearances
- Cook Ob/Gyn — 3 clearances
- Pharmacia, Inc. — 3 clearances
- Axcan Scientific Corp. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
