Cleared Traditional

K150969 - Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

K150969 is an FDA 510(k) clearance for Unidrive S III ENT 40701601-1 with KARL..., manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K150969 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
270d
Days
Class 2
Risk

K150969 is an FDA 510(k) clearance for the Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handp.... 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 January 8, 2016 after a review of 270 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

FDA 510(k) Submission Details - K150969

510(k) Number K150969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2015
Decision Date January 08, 2016
Days to Decision 270 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
180d slower than avg
Panel avg: 90d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ERL Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K150969.
DragonFly Surgical Drill System
K161376 · Grace Medical, Inc. · Aug 2016
PolypVac Microdebrider (3.3mm and 4.0mm)
K161101 · Laurimed, LLC · Jun 2016
DIEGO ELITE DRILL
K152744 · Gyrus Acmi, Inc. · Jun 2016
Pi Drive Plus Motor, Extender
K152641 · Stryker Corporation · Nov 2015
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K150728 · Medtronic Xomed, Inc. · Aug 2015
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
K143492 · Bien-Air Surgery SA · Mar 2015