Cleared Traditional

K965080 - ANSPACH MICROMAX SYSTEM

K965080 is the FDA 510(k) clearance for ANSPACH MICROMAX SYSTEM by The Anspach Effort, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K965080 · The Anspach Effort, Inc. · Ear, Nose, Throat device
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Jan 1997
Decision
22d
Days
Class 2
Risk

K965080 is an FDA 510(k) clearance for the ANSPACH MICROMAX SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 22 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K965080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date January 10, 1997
Days to Decision 22 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
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 54
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K965080.
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584 · Stryker Endoscopy · Oct 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453 · Xomed, Inc. · Sep 1997
APEX UNIVERSAL DRIVE SYSTEM
K964548 · Linvatec Corp. · 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