510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831212Substantially Equivalent

Endoscann

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

K831212 is the FDA 510(k) clearance record for ENDOSCANN, a class II device, cleared for Axcan Scientific Corp. on under FDA product code HFF (Aspirator, Endometrial). FDA records list 5 510(k) clearances for Axcan Scientific Corp., from to . As of , FDA records show no recalls naming K831212.

Clearance record

Decision date
Received
(428 days to decision)
Product code
HFF Aspirator, Endometrial
Regulation
21 CFR 884.1060
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Axcan Scientific Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HFF

Trailing 12 months

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

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