Diaphragm, Contraceptive (And Accessories)
The Contraceptive Diaphragm (and accessories) is a dome-shaped barrier device placed intravaginally to cover the cervix and prevent sperm from reaching the uterus, often used in combination with spermicide. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification before marketing. The product code is HDW, regulated under 21 CFR 884.5350, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HDW
- Device Class
- FDA class 2
- Regulation Number
- 884.5350
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140305 | CAYA CONTOURED DIAPHRAGM | Aug 26, 2014 | Substantially Equivalent | Kessel Medintim GmbH |
| K080040 | ORTHO ALL-FLEX DIAPHRAGM | Aug 25, 2008 | Substantially Equivalent | Johnson & Johnson Produtos Profissionais Ltda. |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | Jan 23, 2008 | Substantially Equivalent | CooperSurgical, Inc. |
| K800162 | ONCE TM | Feb 11, 1980 | Substantially Equivalent | G.D. Searle and Co. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.