Cleared Traditional

K823440 - MCGEE MODIFIED STAINLESS STEEL PISTON

K823440 is the FDA 510(k) clearance for MCGEE MODIFIED STAINLESS STEEL PISTON by Treace Medical, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETB) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K823440 · Treace Medical, Inc. · Ear, Nose, Throat device
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Dec 1982
Decision
17d
Days
Class 2
Risk

K823440 is an FDA 510(k) clearance for the MCGEE MODIFIED STAINLESS STEEL PISTON. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - 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 K823440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1982
Decision Date December 03, 1982
Days to Decision 17 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
72d faster than avg
Panel avg: 89d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETB Prosthesis, Partial Ossicular Replacement

All 36
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K823440.
CAUSSE SPONGE BOAT
K841353 · Treace Medical, Inc. · Jul 1984
FISCH MODIFIED TEF-WIRE PISTON
K823429 · Treace Medical, Inc. · Dec 1982
CAUSSE TEF-PISTON
K823439 · Treace Medical, Inc. · Dec 1982
SHEA LOCKING BAIL PROSTHESIS
K802873 · Richard'S Medical Equip., Inc. · Dec 1980
SCHURING OSSICLE CUP & COLUMELLA PROSTH.
K802431 · Richard'S Medical Equip., Inc. · Nov 1980
TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY
K760434 · Richard'S Medical Equip., Inc. · Oct 1976