HDW — Diaphragm, Contraceptive (And Accessories) Class II
FDA product code HDW covers "Diaphragm, Contraceptive (And Accessories)", a Class II medical device regulated under 21 CFR 884.5350. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HDW
- Device Class
- Class II
- Regulation Number
- 884.5350
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K140305 | kessel medintim | CAYA CONTOURED DIAPHRAGM | August 26, 2014 |
| K080040 | johnson and johnson produtos profissionais ltda | ORTHO ALL-FLEX DIAPHRAGM | August 25, 2008 |
| K063223 | coopersurgical | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL | January 23, 2008 |
| K800162 | g.d. searle and | ONCE TM | February 11, 1980 |