510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PKNClass II

Dilator, Cervical, Synthetic, Osmotic

21 CFR 884.4260 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PKN is the FDA product code for Dilator, Cervical, Synthetic, Osmotic, a class II device type, regulated under 21 CFR 884.4260. FDA's definition for this code reads: "Cervical softening and dilation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PKN
Device name
Dilator, Cervical, Synthetic, Osmotic
FDA definition
Cervical softening and dilation
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code PKN

By decision year
1 clearance under product code PKN with a decision year between 2015 and 2015, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PKN by decision year
YearClearances
20151

Applicants with the most clearances

Product code PKN
Applicants holding the most 510(k) clearances under product code PKN
ApplicantClearances
Medicem Technology s.r.o1

Companies listing this code with FDA

Companies whose registered establishments list this code