DeviceClearance

Product code PKN— Obstetrics/Gynecology

Dilapan-S

Classification name
Dilator, Cervical, Synthetic, Osmotic
Device class
Class 2
Regulation
21 CFR 884.4260
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Cervical softening and dilation”

— U.S. Food and Drug Administration, device classification record for product code PKN under 21 CFR 884.4260, via openFDA

Market context for product code PKN

FDA has cleared 1 device under product code PKN, all in 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PKN

Recent clearances under product code PKN

Data sourced from openFDA. This site is unofficial and independent of the FDA.