Cleared Traditional

K972865 - PROMEX ENT TISSUE REMOVAL SYSTEM

K972865 is an FDA 510(k) clearance for PROMEX ENT TISSUE REMOVAL SYSTEM, manufactured by Promex, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K972865 · Promex, Inc. · Ear, Nose, Throat device
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Sep 1997
Decision
56d
Days
Class 2
Risk

K972865 is an FDA 510(k) clearance for the PROMEX ENT TISSUE REMOVAL SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 29, 1997 after a review of 56 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 Promex, Inc. devices

FDA 510(k) Submission Details - K972865

510(k) Number K972865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1997
Decision Date September 29, 1997
Days to Decision 56 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
33d faster than avg
Panel avg: 89d · This submission: 56d
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 K972865.
SLT BIPOLAR SHEATH
K981041 · Surgical Laser Technologies, Inc. · Aug 1998
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637 · Linvatec Corp. · Jul 1998
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584 · Stryker Endoscopy · Oct 1997
ENT IRRIGATING PUMP (70327700)
K973286 · Gyrus Ent LLC · Sep 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453 · Xomed, Inc. · Sep 1997
APEX UNIVERSAL DRIVE SYSTEM
K964548 · Linvatec Corp. · Jan 1997