510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822365Substantially Equivalent

Centurion Skin Staple Remover

Tri-State, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822365 is the FDA 510(k) clearance record for CENTURION SKIN STAPLE REMOVER, a class I device, cleared for Tri-State on under FDA product code GDT (Staple, Removable (Skin)). FDA records list one 510(k) clearance for Tri-State. As of , FDA records show no recalls naming K822365.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GDT Staple, Removable (Skin)
Regulation
21 CFR 878.4760
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Tri-State 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GDT

Trailing 12 months

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

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