Cleared Traditional

K034004 - DIEGO RF POWERED DISSECTOR AND DRILL SY...

K034004 is the FDA 510(k) clearance for DIEGO RF POWERED DISSECTOR AND DRILL SY... by Gyrus Ent LLC. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K034004 · Gyrus Ent LLC · Ear, Nose, Throat device
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Mar 2004
Decision
70d
Days
Class 2
Risk

K034004 is an FDA 510(k) clearance for the DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on March 3, 2004 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - 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 Gyrus Ent LLC devices

Submission Details

510(k) Number K034004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date March 03, 2004
Days to Decision 70 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 89d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 58
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K034004.
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
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XPS 3000 SYSTEM
K041523 · Medtronic Xomed, Inc. · Jul 2004
XPS 3000 SYSTEM
K041413 · Medtronic Xomed, Inc. · Jul 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · Stryker Instruments · Mar 2004
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · Gyrus Ent LLC · Mar 2002
MODIFICATION TO XPS 3000 SYSTEM
K011321 · Medtronic Xomed, Inc. · Jun 2001