Cleared Traditional

K971124 - TM MICRO-CATHETERS

K971124 is an FDA 510(k) clearance for TM MICRO-CATHETERS, manufactured by Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K971124 · Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
50d
Days
Class 2
Risk

K971124 is an FDA 510(k) clearance for the TM MICRO-CATHETERS. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 16, 1997 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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 Xomed, Inc. devices

FDA 510(k) Submission Details - K971124

510(k) Number K971124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1997
Decision Date May 16, 1997
Days to Decision 50 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
40d faster than avg
Panel avg: 90d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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 - ETD Tube, Tympanostomy

All 89
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K971124.
MYRINGOTOMY TUBE
K971943 · Mednet Locator, Inc. · Jul 1997
MYRINGOTOMY TUBE - BOBBIN WITH TAB
K972400 · Mednet Locator, Inc. · Jul 1997
TYMPANOSTOMY VENTILATION TUBE
K971454 · Ikonos Corp. · May 1997
ROUND WINDOW CATH
K965115 · Neuro-Biometrix, Inc. · Mar 1997
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
K963727 · Medtronic Xomed · Feb 1997
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996