510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131206Substantially Equivalent

Cook Cervical Ripening Balloon

Cook Inc., Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131206 is the FDA 510(k) clearance record for COOK CERVICAL RIPENING BALLOON, a class II device, cleared for Cook, Inc. on under FDA product code PFJ (Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor). FDA's definition for product code PFJ reads: "Mechanical dilation of the cervical canal for labor". FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K131206.

Clearance record

Decision date
Received
(151 days to decision)
Product code
PFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cook, Inc. 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFJ

Trailing 12 months

FDA records hold no clearances under product code PFJ in the trailing twelve months.

FDA records show no clearances under product code PFJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260