Cleared Traditional

K020594 - DIEGO POWERED DISSECTOR AND DRILL SYSTEM

K020594 is the FDA 510(k) clearance for DIEGO POWERED DISSECTOR AND DRILL SYSTEM 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 14-day FDA review.

K020594 · Gyrus Ent LLC · Ear, Nose, Throat device
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Mar 2002
Decision
14d
Days
Class 2
Risk

K020594 is an FDA 510(k) clearance for the DIEGO POWERED DISSECTOR AND DRILL SYSTEM. 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 8, 2002 after a review of 14 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 K020594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2002
Decision Date March 08, 2002
Days to Decision 14 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
75d faster than avg
Panel avg: 89d · This submission: 14d
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 K020594.
XPS 3000 SYSTEM
K041413 · Medtronic Xomed, Inc. · Jul 2004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004 · Gyrus Ent LLC · Mar 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · Stryker Instruments · Mar 2004
MODIFICATION TO XPS 3000 SYSTEM
K011321 · Medtronic Xomed, Inc. · Jun 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · Stryker Instruments · May 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · KARL STORZ Endoscopy-America, Inc. · Apr 2001