Cleared Traditional

K940016 - ELECTRIC SURGICAL DRILL

K940016 is an FDA 510(k) clearance for ELECTRIC SURGICAL DRILL, manufactured by Alamo City Dental Supply Co.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K940016 · Alamo City Dental Supply Co. · Ear, Nose, Throat device
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Nov 1994
Decision
322d
Days
Class 2
Risk

K940016 is an FDA 510(k) clearance for the ELECTRIC SURGICAL DRILL. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Alamo City Dental Supply Co. (San Antonio, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Alamo City Dental Supply Co. devices

FDA 510(k) Submission Details - K940016

510(k) Number K940016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1994
Decision Date November 22, 1994
Days to Decision 322 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 89d · This submission: 322d
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 59
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K940016.
INTRAARC DRIVE SYSTEM
K951263 · Linvatec Corp. · Apr 1995
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
STRYKER TOTAL PERFORMANCE SYSTEM
K943569 · Stryker Corp. · Jan 1995
APEX UNIVERSAL DRIVE SYSTEM
K944476 · Linvatec Corp. · Nov 1994
STRYKER MICRODEBRIDER SYSTEM
K940710 · Stryker Corp. · May 1994
TREACE MAGNUM OTO-TOOL SYSTEM
K873154 · Treace Medical, Inc. · Sep 1987