HDW · Diaphragm, Contraceptive (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.5350 · Class 2
Overview
| Product Code | HDW |
|---|---|
| Device Name | Diaphragm, Contraceptive (And Accessories) |
| Regulation | 21 CFR 884.5350 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140305 | CAYA CONTOURED DIAPHRAGM | Kessel Medintim GmbH | Aug 26, 2014 | SESE |
| K080040 | ORTHO ALL-FLEX DIAPHRAGM | Johnson & Johnson Produtos Profissionais Ltda. | Aug 25, 2008 | SESE |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | CooperSurgical, Inc. | Jan 23, 2008 | SESE |
| K800162 | ONCE TM | G.D. Searle and Co. | Feb 11, 1980 | SESE |
Top Applicants
- CooperSurgical, Inc. — 1 clearance
- G.D. Searle and Co. — 1 clearance
- Johnson & Johnson Produtos Profissionais Ltda. — 1 clearance
- Kessel Medintim GmbH — 1 clearance
