MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
FDA 510(k) clearance K063223 · decided 2008-01-23
Clearance details
- K-number
- K063223
- Device name
- MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
- Applicant
- CooperSurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-24
- Decision date
- 2008-01-23
- Days to decision
- 456 days
- Clearance type
- Traditional
- Product code
- HDW
- Device class
- 2
- Regulation number
- 884.5350
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch CooperSurgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CAYA CONTOURED DIAPHRAGM (K140305) | Kessel Medintim GmbH | 2014-08-26 |
| ORTHO ALL-FLEX DIAPHRAGM (K080040) | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 |
| ONCE TM (K800162) | G.D. Searle and Co. | 1980-02-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Milex Arcing Diaphragm Size 95; Model Number: MXWS95 recall (Z-1054-2016) | CooperSurgical, Inc. | 2016-03-04 |
| MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 recall (Z-1814-2015) | CooperSurgical, Inc. | 2015-06-18 |
| Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Int recall (Z-1018-2013) | Cooper Surgical, Inc. | 2013-03-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Mara Water Vapor Ablation System (P160047/S039) | CooperSurgical, Inc. | 2025-01-07 |
| MARA Water Vapor Ablation System (P160047/S035) | CooperSurgical, Inc. | 2024-07-11 |
| MARA Water Vapor Ablation System (P160047/S038) | CooperSurgical, Inc. | 2024-07-09 |
| MARA Water Vapor Ablation System (P160047/S036) | CooperSurgical, Inc. | 2024-05-10 |
| Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034) | CooperSurgical, Inc. | 2023-12-08 |
| MARA Water Vapor Ablation System (P160047/S033) | CooperSurgical, Inc. | 2023-10-25 |
| Mara Water Vapor Ablation System (P160047/S031) | CooperSurgical, Inc. | 2023-07-28 |
| Mara Water Vapor Ablation System (P160047/S032) | CooperSurgical, Inc. | 2023-07-27 |