510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062523Substantially Equivalent

Tru-Mr Laryngoscope Set

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

K062523 is the FDA 510(k) clearance record for TRU-MR LARYNGOSCOPE SET, a class I device, cleared for Truphatek International, Ltd. on under FDA product code CCW (Laryngoscope, Rigid). FDA records list 2 510(k) clearances for Truphatek International, Ltd., from to . As of , FDA records show one recall naming K062523.

Clearance record

Decision date
Received
(81 days to decision)
Product code
CCW Laryngoscope, Rigid
Regulation
21 CFR 868.5540
Device class
Class I
Review panel
Anesthesiology
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 CCW

Trailing 12 months

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

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