Cleared Traditional

K872791 - POREX NERVE LOCATOR

K872791 is an FDA 510(k) clearance for POREX NERVE LOCATOR, manufactured by Porex Medical. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K872791 · Porex Medical · Ear, Nose, Throat device
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Oct 1987
Decision
98d
Days
Class 2
Risk

K872791 is an FDA 510(k) clearance for the POREX NERVE LOCATOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 98 days - within the typical 510(k) review window.

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 Porex Medical devices

FDA 510(k) Submission Details - K872791

510(k) Number K872791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date October 20, 1987
Days to Decision 98 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 90d · This submission: 98d
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 68
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K872791.
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MONTGOMERY NERVE STIMULATOR
K880720 · Boston Medical Products, Inc. · May 1988
NICOLET DISPOSABLE PRASS PROBE
K873964 · Nicolet Biomedical Instruments · Nov 1987
MODEL 6110C OTOPHOR
K870272 · Life-Tech Intl., Inc. · Aug 1987
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · Edward Weck, Inc. · Feb 1984
NEUROTRAC
K831715 · Hdc Corp. · Jul 1983