510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854517Substantially Equivalent

New Travenol Roller Clamp-Solution Admin. Set

Travenol Laboratories, S.A., Deerfield IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854517 is the FDA 510(k) clearance record for NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET, a class I device, cleared for Travenol Laboratories, S.A. on under FDA product code FKK (Clamp, Line). FDA records list 206 510(k) clearances for Travenol Laboratories, S.A., from to . As of , FDA records show no recalls naming K854517.

Clearance record

Decision date
Received
(20 days to decision)
Product code
FKK Clamp, Line
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Travenol Laboratories, S.A.
Third party review
No

Clearances, product code FKK

Trailing 12 months

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

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