510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810227Substantially Equivalent

Model #53110 Disposable Anoscope

Welch Allyn Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810227 is the FDA 510(k) clearance record for MODEL #53110 DISPOSABLE ANOSCOPE, a class II device, cleared for Welch Allyn, 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 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K810227.

Clearance record

Decision date
Received
(23 days to decision)
Product code
FER Anoscope And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Welch Allyn, Inc. 803 N. Front St. Suite 3, Mchenry IL
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