Cleared Traditional

K823436 - MICROSURGICAL GAUGE

K823436 is the FDA 510(k) clearance for MICROSURGICAL GAUGE by Treace Medical, Inc.. It is a Class 1 Ear, Nose, Throat device (product code EQH) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K823436 · Treace Medical, Inc. · Ear, Nose, Throat device
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Dec 1982
Decision
23d
Days
Class 1
Risk

K823436 is an FDA 510(k) clearance for the MICROSURGICAL GAUGE. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K823436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1982
Decision Date December 09, 1982
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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.

Regulatory Peers - EQH Source, Carrier, Fiberoptic Light

All 24
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K823436.
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K854751 · Aspen Laboratories, Inc. · Feb 1986
VENT TUBE FORCEPS
K831589 · Treace Medical, Inc. · Jun 1983
T-TUBE INSERTER
K831590 · Treace Medical, Inc. · Jun 1983
MCGEE 26GA. SUCTION TUBE
K823437 · Treace Medical, Inc. · Dec 1982
LARYNGEAL SPATULAS
K822259 · Kelleher Corp. · Oct 1982
FIBEROPTIC LIGHT CARRIERS
K822282 · Kelleher Corp. · Aug 1982