Cleared Traditional

SYN-O-SCOPE NASAL INHALER (K760674) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K760674 · Mcdonald and Assoc., Inc. · Ear, Nose, Throat device
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Mar 1977
Decision
175d
Days
Class 1
Risk

K760674 is an FDA 510(k) clearance for the SYN-O-SCOPE NASAL INHALER. Classified as Nasal Spray, Ent Delivery (product code KCO), Class I - General Controls.

Submitted by Mcdonald and Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977 after a review of 175 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Mcdonald and Assoc., Inc. devices

Submission Details

510(k) Number K760674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1976
Decision Date March 10, 1977
Days to Decision 175 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 89d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCO Nasal Spray, Ent Delivery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.