Cleared Special

K141935 - STRYKER S2 DRILL

K141935 is an FDA 510(k) clearance for STRYKER S2 DRILL, manufactured by Stryker Corporation. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Special 510(k) pathway after a 71-day FDA review.

K141935 · Stryker Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
71d
Days
Class 2
Risk

K141935 is an FDA 510(k) clearance for the STRYKER S2 DRILL. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on September 26, 2014 after a review of 71 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141935

510(k) Number K141935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2014
Decision Date September 26, 2014
Days to Decision 71 days
Submission Type Special
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: 90d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 84
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K141935.
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K141935 · STRYKER S2 DRILL
Download PDF FDA Summary Stryker Corporation