510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K945590Substantially Equivalent

Scopetex(tm)

Smith Helms Mulliss & Moore, L.L.P., Greensboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945590 is the FDA 510(k) clearance record for SCOPETEX(TM), a class I device, cleared for Smith Helms Mulliss & Moore, L.L.P. on under FDA product code CCW (Laryngoscope, Rigid). FDA records list one 510(k) clearance for Smith Helms Mulliss & Moore, L.L.P. As of , FDA records show no recalls naming K945590.

Clearance record

Decision date
Received
(918 days to decision)
Product code
CCW Laryngoscope, Rigid
Regulation
21 CFR 868.5540
Device class
Class I
Review panel
Anesthesiology
Applicant
Smith Helms Mulliss & Moore, L.L.P. Post Office Box 21927, Greensboro NC
510(k) summary
Statement
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