Dilator, Cervical, Synthetic, Osmotic
The Dilator, Cervical, Synthetic, Osmotic (product code PKN) is an obstetrics and gynecology device used for cervical softening and dilation, classified as FDA Class 2 under regulation 884.4260. It requires 510(k) clearance and is eligible for third-party review. The device is not flagged as an implant or life-sustaining product.
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Basic Information
- Product Code
- PKN
- Device Class
- FDA class 2
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Cervical softening and dilation
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K143447 | Dilapan-S | Apr 17, 2015 | Substantially Equivalent | Medicem Technology S.R.O |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.