Cleared Traditional

K940710 - STRYKER MICRODEBRIDER SYSTEM

K940710 is an FDA 510(k) clearance for STRYKER MICRODEBRIDER SYSTEM, manufactured by Stryker Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K940710 · Stryker Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
88d
Days
Class 2
Risk

K940710 is an FDA 510(k) clearance for the STRYKER MICRODEBRIDER SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 88 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.

FDA 510(k) Submission Details - K940710

510(k) Number K940710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1994
Decision Date May 16, 1994
Days to Decision 88 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
2d faster than avg
Panel avg: 90d · This submission: 88d
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 90
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K940710.
EDI-BUR MICRODRILL SYSTEMS
K945438 · Micromed Development Corp. · Nov 1994
APEX UNIVERSAL DRIVE SYSTEM
K944476 · Linvatec Corp. · Nov 1994
MEDNEXT MICRO-DRILL
K943108 · Mednext, Inc. · Aug 1994
DRILL MODULES MODELS 2116/2117
K914346 · Micro Surgical Instruments Corp. · Nov 1991
X-T AIR DRILL
K905800 · Xomed-Treace, Inc. · Apr 1991
TREACE MAGNUM OTO-TOOL SYSTEM
K873154 · Treace Medical, Inc. · Sep 1987
K940710 · STRYKER MICRODEBRIDER SYSTEM
Download PDF FDA Summary Stryker Corp.