510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K760674Substantially Equivalent

Syn-O-Scope Nasal Inhaler

Mcdonald and Assoc., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760674 is the FDA 510(k) clearance record for SYN-O-SCOPE NASAL INHALER, a class I device, cleared for Mcdonald and Assoc., Inc. on under FDA product code KCO (Nasal Spray, Ent Delivery). FDA records list one 510(k) clearance for Mcdonald and Assoc., Inc. As of , FDA records show no recalls naming K760674.

Clearance record

Decision date
Received
(175 days to decision)
Product code
KCO Nasal Spray, Ent Delivery
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Mcdonald and Assoc., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KCO

Trailing 12 months

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

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