510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960421Substantially Equivalent

Sinuscan 102/Sinusprint

Ferguson Medical, Chico CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960421 is the FDA 510(k) clearance record for SINUSCAN 102/SINUSPRINT, a class II device, cleared for Ferguson Medical on under FDA product code LWI (Ultrasound, Sinus). FDA records list 57 510(k) clearances for Ferguson Medical, from to . As of , FDA records show no recalls naming K960421.

Clearance record

Decision date
Received
(443 days to decision)
Product code
LWI Ultrasound, Sinus
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Ferguson Medical 3407 Bay Ave., Chico CA
510(k) summary
Summary
Third party review
No

Clearances, product code LWI

Trailing 12 months

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

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