510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943288Substantially Equivalent

Amsco Sq240 Surgical Light

American Sterilizer Co., Erie PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943288 is the FDA 510(k) clearance record for AMSCO SQ240 SURGICAL LIGHT, a class II device, cleared for American Sterilizer Co. on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 36 510(k) clearances for American Sterilizer Co., from to . As of , FDA records show no recalls naming K943288.

Clearance record

Decision date
Received
(101 days to decision)
Product code
FSY Light, Surgical, Ceiling Mounted
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
American Sterilizer Co. 2424 W. 23rd St., Erie PA
510(k) summary
Summary
Third party review
No

Clearances, product code FSY

Trailing 12 months

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

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