FDA product code PKN
Dilator, Cervical, Synthetic, Osmotic
Obstetrics/Gynecology·Class 2·21 CFR 884.4260
US regulatory classifications
- US Product Code (FDA)
- PKNView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 884.4260View CFR Regulation →
- Medical specialty
- Obstetrics/Gynecology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
Cervical softening and dilation
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About this record
Dilator, Cervical, Synthetic, Osmotic is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.