Cleared Traditional

K970971 - URO MED NERVE STIMULATOR

K970971 is an FDA 510(k) clearance for URO MED NERVE STIMULATOR, manufactured by Uromed Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K970971 · Uromed Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
224d
Days
Class 2
Risk

K970971 is an FDA 510(k) clearance for the URO MED NERVE STIMULATOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Uromed Corp. (Needham, US). The FDA issued a Cleared decision on October 27, 1997 after a review of 224 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Uromed Corp. devices

FDA 510(k) Submission Details - K970971

510(k) Number K970971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date October 27, 1997
Days to Decision 224 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
135d slower than avg
Panel avg: 89d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 - ETN Stimulator, Nerve

All 42
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K970971.
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc. · Jan 2002
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · Xomed, Inc. · Oct 1999
NIM4
K982595 · Xomed, Inc. · Sep 1998
NEURO PULSE II,III
K971143 · Aaron Medical Industries · Jun 1997
STIMULATING SURGICAL INSTRUMENTS
K934733 · Smith & Nephew Richards, Inc. · Jul 1994
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
K933491 · R & D Batteries, Inc. · Nov 1993