510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964586Substantially Equivalent

Prescott's Light Source Model No. II-150

Iba/Griffith, Monument CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964586 is the FDA 510(k) clearance record for PRESCOTT'S LIGHT SOURCE MODEL NO. II-150, a class II device, cleared for Iba/Griffith on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list one 510(k) clearance for Iba/Griffith. As of , FDA records show no recalls naming K964586.

Clearance record

Decision date
Received
(63 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Iba/Griffith P.O. Box 609, Monument CO
510(k) summary
Statement
Third party review
No

Clearances, product code FCW

Trailing 12 months

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

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