510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002255Substantially Equivalent

Laryngo-Tracheal Mucosal Atomization Device (Madgic)

Wolfe Tory Medical, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002255 is the FDA 510(k) clearance record for LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC), a class II device, cleared for Wolfe Tory Medical, Inc. on under FDA product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia). FDA records list 5 510(k) clearances for Wolfe Tory Medical, Inc., from to . As of , FDA records show no recalls naming K002255.

Clearance record

Decision date
Received
(55 days to decision)
Product code
CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Regulation
21 CFR 868.5170
Device class
Class II
Review panel
Anesthesiology
Applicant
Wolfe Tory Medical, Inc. 79 W. 4500 S., Suite 21, Salt Lake City UT
510(k) summary
Summary
Third party review
No

Clearances, product code CCT

Trailing 12 months

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

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