Cleared Traditional

K833606 - IMPLANT MEASURING GAUGE

K833606 is an FDA 510(k) clearance for IMPLANT MEASURING GAUGE, manufactured by Microtek Medical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code JYJ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K833606 · Microtek Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
83d
Days
Class 1
Risk

K833606 is an FDA 510(k) clearance for the IMPLANT MEASURING GAUGE. Classified as Gauge, Measuring (product code JYJ), Class I - General Controls.

Submitted by Microtek Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 Microtek Medical, Inc. devices

FDA 510(k) Submission Details - K833606

510(k) Number K833606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 03, 1984
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 90d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

JYJ Device Classification - Class 1, General Controls

Product Code JYJ Gauge, Measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.