510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831224Substantially Equivalent

Augros Hysterometer

Axcan Scientific Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831224 is the FDA 510(k) clearance record for AUGROS HYSTEROMETER, a class I device, cleared for Axcan Scientific Corp. on under FDA product code HHM (Sound, Uterine). FDA records list 5 510(k) clearances for Axcan Scientific Corp., from to . As of , FDA records show no recalls naming K831224.

Clearance record

Decision date
Received
(196 days to decision)
Product code
HHM Sound, Uterine
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Axcan Scientific Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HHM

Trailing 12 months

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

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