Cleared Traditional

K831946 - SURGICAL DRILL-ELECTRIC-HANDPIECE

K831946 is the FDA 510(k) clearance for SURGICAL DRILL-ELECTRIC-HANDPIECE by Entronics. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K831946 · Entronics · Ear, Nose, Throat device
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Nov 1983
Decision
140d
Days
Class 2
Risk

K831946 is an FDA 510(k) clearance for the SURGICAL DRILL-ELECTRIC-HANDPIECE. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Entronics (Walker, US). The FDA issued a Cleared decision on November 3, 1983 after a review of 140 days - within the typical 510(k) review window.

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 Entronics devices

Submission Details

510(k) Number K831946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1983
Decision Date November 03, 1983
Days to Decision 140 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 89d · This submission: 140d
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 55
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K831946.
TREACE DRILL SYSTEM
K862807 · Treace Medical, Inc. · Aug 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331 · Micro-Aire Surgical Instruments, Inc. · Jan 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332 · Micro-Aire Surgical Instruments, Inc. · Jan 1986
TORX OR TYPE MICRO MOTOR HANDPIECE
K822008 · Kelleher Corp. · Aug 1982
FISCH DRILL SYSTEM
K792159 · Jedmed Instrument Co. · Nov 1979
WOMED NICRO-CRAFT POWER SYSTEM
K791407 · Xomed, Inc. · Aug 1979