Cleared Traditional

K954715 - MICRO-PLANER HANDPIECE

K954715 is an FDA 510(k) clearance for MICRO-PLANER HANDPIECE, manufactured by Trebay 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 15-day FDA review.

K954715 · Trebay Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
15d
Days
Class 2
Risk

K954715 is an FDA 510(k) clearance for the MICRO-PLANER HANDPIECE. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 15 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 Trebay Medical Corp. devices

FDA 510(k) Submission Details - K954715

510(k) Number K954715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1995
Decision Date October 27, 1995
Days to Decision 15 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 89d · This submission: 15d
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 K954715.
APEX UNIVERSAL DRIVE SYSTEM
K964548 · Linvatec Corp. · Jan 1997
ANSPACH MICROMAX SYSTEM
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
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · KARL STORZ Endoscopy-America, Inc. · Mar 1995