Cleared Traditional

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL (K962163) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962163 · Misten Medical Corp. · Ear, Nose, Throat device
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Jul 1996
Decision
51d
Days
Class 2
Risk

K962163 is an FDA 510(k) clearance for the MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Misten Medical Corp. (Germantown, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 51 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 Misten Medical Corp. devices

Submission Details

510(k) Number K962163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1996
Decision Date July 25, 1996
Days to Decision 51 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
38d faster than avg
Panel avg: 89d · This submission: 51d
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 14
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K962163.
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 · KARL STORZ Endoscopy-America, Inc. · Jan 2016
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262 · KARL STORZ Endoscopy-America, Inc. · Dec 2005
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · KARL STORZ Endoscopy-America, Inc. · Apr 2001
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · KARL STORZ Endoscopy-America, Inc. · Mar 1995