Cleared Traditional

K993234 - MICROMEDICS S&T PARTIAL OSSICULAR REPLA...

K993234 is the FDA 510(k) clearance for MICROMEDICS S&T PARTIAL OSSICULAR REPLA... by Micromedics, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETB) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K993234 · Micromedics, Inc. · Ear, Nose, Throat device
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Nov 1999
Decision
44d
Days
Class 2
Risk

K993234 is an FDA 510(k) clearance for the MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on November 10, 1999 after a review of 44 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 Micromedics, Inc. devices

Submission Details

510(k) Number K993234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date November 10, 1999
Days to Decision 44 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 89d · This submission: 44d
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 29
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K993234.
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
TITANIUM MIDDLE EAR PROSTHESES
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EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
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MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997