510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133554Substantially Equivalent

Surgical Light Handle Cover

Microtek Medical, Inc. an Ecolab Company, Saint Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133554 is the FDA 510(k) clearance record for SURGICAL LIGHT HANDLE COVER, a class II device, cleared for Microtek Medical, Inc. an Ecolab Company on under FDA product code FTA (Light, Surgical, Accessories). FDA records list one 510(k) clearance for Microtek Medical, Inc. an Ecolab Company. As of , FDA records show no recalls naming K133554.

Clearance record

Decision date
Received
(140 days to decision)
Product code
FTA Light, Surgical, Accessories
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Microtek Medical, Inc. an Ecolab Company 370 Wabasha St. N., Saint Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTA

Trailing 12 months

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

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