510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854922Substantially Equivalent

Amsco Polaris Sl

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

K854922 is the FDA 510(k) clearance record for AMSCO POLARIS SL, a class II device, cleared for Amsco Co. on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 2 510(k) clearances for Amsco Co., from to . As of , FDA records show no recalls naming K854922.

Clearance record

Decision date
Received
(45 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
Amsco Co. 2424 W. 23rd St., Erie PA
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