Cleared Traditional

K962163 - MISTEN MEDICAL MISTEN MEDICAL SURGICAL ...

K962163 is an FDA 510(k) clearance for MISTEN MEDICAL MISTEN MEDICAL SURGICAL ..., manufactured by Misten Medical Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 51-day FDA review.

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

FDA 510(k) Submission Details - K962163

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.

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 K962163.
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K965080 · The Anspach Effort, Inc. · Jan 1997
IRRIGATION SYSTEM
K961192 · Linvatec Corp. · Apr 1996
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K952681 · Stryker Endoscopy · Jul 1995
INTRAARC DRIVE SYSTEM
K951263 · Linvatec Corp. · Apr 1995