Cleared Traditional

PHYSICIANS CHOICE SILICONE EAR PUTTY (K823921) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K823921 · Santa Barbara Medco, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.