Okamoto USA, Inc.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest FDA decision2026-05-04
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252622 | Male Latex Condom HA | HIS | 2026-05-04 | View |
| 510(k) | K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | HIS | 2025-02-18 | View |
| 510(k) | K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | MOL | 2022-02-25 | View |
| 510(k) | K192669 | Extremely Thin 003, ZERO ZERO THREE | HIS | 2020-07-24 | View |
No matching devices.