PKN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dilator, Cervical, Synthetic, Osmotic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- FDA definition
- Cervical softening and dilation
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Dilapan-S (K143447) | Medicem Technology S.R.O | 2015-04-17 |
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