Cleared Traditional

K200318 - UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200318 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
258d
Days
Class 2
Risk

K200318 is an FDA 510(k) clearance for the UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shav.... Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on October 22, 2020 after a review of 258 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K200318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2020
Decision Date October 22, 2020
Days to Decision 258 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 89d · This submission: 258d
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 90
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K200318.
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