Cleared Traditional

K823921 - PHYSICIANS CHOICE SILICONE EAR PUTTY

K823921 is an FDA 510(k) clearance for PHYSICIANS CHOICE SILICONE EAR PUTTY, manufactured by Santa Barbara Medco, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LDG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K823921 · Santa Barbara Medco, Inc. · Ear, Nose, Throat device
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Mar 1983
Decision
90d
Days
Class 1
Risk

K823921 is an FDA 510(k) clearance for the PHYSICIANS CHOICE SILICONE EAR PUTTY. Classified as Kit, Earmold, Impression (product code LDG), Class I - General Controls.

Submitted by Santa Barbara Medco, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 28, 1983 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 Santa Barbara Medco, Inc. devices

FDA 510(k) Submission Details - K823921

510(k) Number K823921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1982
Decision Date March 28, 1983
Days to Decision 90 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
At panel average
Panel avg: 90d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LDG Device Classification - Class 1, General Controls

Product Code LDG Kit, Earmold, Impression
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
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.