Cleared Traditional

K914346 - DRILL MODULES MODELS 2116/2117

K914346 is an FDA 510(k) clearance for DRILL MODULES MODELS 2116/2117, manufactured by Micro Surgical Instruments Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K914346 · Micro Surgical Instruments Corp. · Ear, Nose, Throat device
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Nov 1991
Decision
61d
Days
Class 2
Risk

K914346 is an FDA 510(k) clearance for the DRILL MODULES MODELS 2116/2117. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 61 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Surgical Instruments Corp. devices

FDA 510(k) Submission Details - K914346

510(k) Number K914346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date November 27, 1991
Days to Decision 61 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
29d faster than avg
Panel avg: 90d · This submission: 61d
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 72
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K914346.
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K854331 · Micro-Aire Surgical Instruments, Inc. · Jan 1986