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
K013242Substantially Equivalent

Amsco Harmony Surgical Lighting and Media System

STERIS Corporation, Montgomery AL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K013242 is the FDA 510(k) clearance record for AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM, a class II device, cleared for STERIS Corporation on under FDA product code FTD (Lamp, Surgical). FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show 4 recalls naming K013242.

Clearance record

Decision date
Received
(76 days to decision)
Product code
FTD Lamp, Surgical
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
STERIS Corporation 2720 Gunter Park E., Montgomery AL
510(k) summary
Summary
Third party review
No

Clearances, product code FTD

Trailing 12 months

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

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