510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983947Substantially Equivalent

Amerse 2

STERIS Corporation, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983947 is the FDA 510(k) clearance record for AMERSE 2, a class I device, cleared for STERIS Corporation on under FDA product code LRJ (Disinfectant, Medical Devices). FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show no recalls naming K983947.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LRJ Disinfectant, Medical Devices
Regulation
21 CFR 880.6890
Device class
Class I
Review panel
General Hospital
Applicant
STERIS Corporation 5035 Manchester Ave., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code LRJ

Trailing 12 months

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

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