510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863439Substantially Equivalent

Intrauterine Hemostasis Balloon Stent

Mentor, Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863439 is the FDA 510(k) clearance record for INTRAUTERINE HEMOSTASIS BALLOON STENT, a class II device, cleared for Mentor Corp. on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list 65 510(k) clearances for Mentor Corp., from to . As of , FDA records show no recalls naming K863439.

Clearance record

Decision date
Received
(270 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
Mentor Corp. 600 Pine Ave., Goleta CA
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