510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053321Substantially Equivalent

Light Guard Light Handle and Light Handle Cover

Xodus Medical Inc, New Kensington PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053321 is the FDA 510(k) clearance record for LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER, a class II device, cleared for Xodus Medical, Inc. on under FDA product code FTA (Light, Surgical, Accessories). FDA records list 6 510(k) clearances for Xodus Medical, Inc., from to . As of , FDA records show no recalls naming K053321.

Clearance record

Decision date
Received
(50 days to decision)
Product code
FTA Light, Surgical, Accessories
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Xodus Medical, Inc. 702 Prominence Dr., New Kensington PA
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