510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861017Substantially Equivalent

Galenica's Disposable Anoscopes

Galenica Enterprises, Inc., Quebec Canada J7e 4h7, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861017 is the FDA 510(k) clearance record for GALENICA'S DISPOSABLE ANOSCOPES, a class II device, cleared for Galenica Enterprises, Inc. on under FDA product code FER (Anoscope And Accessories). FDA's definition for product code FER reads: "To examine and perform procedures within the anus and rectum". FDA records list 5 510(k) clearances for Galenica Enterprises, Inc., from to . As of , FDA records show no recalls naming K861017.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FER Anoscope And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Galenica Enterprises, Inc. C.p. 13, Quebec Canada J7e 4h7, CA
Third party review
No

Clearances, product code FER

Trailing 12 months

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

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