Cleared Traditional

K972584 - STRYKER HUMMER II MICRODEBRIDER SYSTEM

K972584 is an FDA 510(k) clearance for STRYKER HUMMER II MICRODEBRIDER SYSTEM, manufactured by Stryker Endoscopy. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K972584 · Stryker Endoscopy · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
83d
Days
Class 2
Risk

K972584 is an FDA 510(k) clearance for the STRYKER HUMMER II MICRODEBRIDER SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 83 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 Stryker Endoscopy devices

FDA 510(k) Submission Details - K972584

510(k) Number K972584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date October 01, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 90d · This submission: 83d
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 70
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K972584.
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637 · Linvatec Corp. · Jul 1998
ULTRABUR
K974174 · Mednet Locator, Inc. · Mar 1998
POWERTREK INSTRUMENTS
K972057 · Medtrek Corp. · Nov 1997
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865 · Promex, Inc. · Sep 1997
ENT IRRIGATING PUMP (70327700)
K973286 · Gyrus Ent LLC · Sep 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453 · Xomed, Inc. · Sep 1997