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

Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

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

PFJ is the FDA product code for Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor, a class II device type, regulated under 21 CFR 884.4260. FDA's definition for this code reads: "Mechanical dilation of the cervical canal for labor". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PFJ
Device name
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
FDA definition
Mechanical dilation of the cervical canal for labor.
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
2
Ingested recalls
1

Clearances, product code PFJ

By decision year
2 clearances under product code PFJ with a decision year between 2013 and 2015, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFJ by decision year
YearClearances
20131
20151

Applicants with the most clearances

Product code PFJ
Applicants holding the most 510(k) clearances under product code PFJ
ApplicantClearances
Cook Inc.1
Utah Medical Products, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code