510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062438Substantially Equivalent

Bakri Postpartum Balloon, Model J-Sos-100500

Cook Ob/Gyn, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062438 is the FDA 510(k) clearance record for BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500, a class II device, cleared for Cook Ob/Gyn on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list 43 510(k) clearances for Cook Ob/Gyn, from to . As of , FDA records show no recalls naming K062438.

Clearance record

Decision date
Received
(67 days to decision)
Product code
KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cook Ob/Gyn 1100 W. Morgan St., Spencer IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNA

Trailing 12 months

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

FDA records show no clearances under product code KNA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNA, 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