510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063309Substantially Equivalent

Tru-Cable

Truphatek International, Ltd., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063309 is the FDA 510(k) clearance record for TRU-CABLE, a class II device, cleared for Truphatek International, Ltd. on under FDA product code FFS (Image, Illumination, Fiberoptic, For Endoscope). FDA records list 2 510(k) clearances for Truphatek International, Ltd., from to . As of , FDA records show no recalls naming K063309.

Clearance record

Decision date
Received
(71 days to decision)
Product code
FFS Image, Illumination, Fiberoptic, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Truphatek International, Ltd. 3460 Pt.e Creek Ct. #102, Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FFS

Trailing 12 months

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

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