510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K761018Substantially Equivalent

Surgical Light - Challenge 22 Series

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

K761018 is the FDA 510(k) clearance record for SURGICAL LIGHT - CHALLENGE 22 SERIES, a class II device, cleared for Amsco Co. on under FDA product code FQP (Lamp, Operating-Room). FDA records list 13 510(k) clearances for Amsco Co., from to . As of , FDA records show no recalls naming K761018.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FQP Lamp, Operating-Room
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Amsco Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FQP

Trailing 12 months

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

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