PKN — Dilator, Cervical, Synthetic, Osmotic Class II
FDA product code PKN covers "Dilator, Cervical, Synthetic, Osmotic", a Class II medical device regulated under 21 CFR 884.4260. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PKN
- Device Class
- Class II
- Regulation Number
- 884.4260
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Cervical softening and dilation
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143447 | medicem technology s.r.o | Dilapan-S | April 17, 2015 |