Cleared Traditional

TABLE, EXAMINING-TWO EIGHTY (K782064) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K782064 · Amsco Co. · Ear, Nose, Throat device
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Dec 1978
Decision
15d
Days
Class 1
Risk

K782064 is an FDA 510(k) clearance for the TABLE, EXAMINING-TWO EIGHTY. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Amsco Co. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1978 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amsco Co. devices

Submission Details

510(k) Number K782064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1978
Decision Date December 28, 1978
Days to Decision 15 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
74d faster than avg
Panel avg: 89d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
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.