Cleared Traditional

K833646 - PULSATRON NERVE LOCATOR/STIMULATOR (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833646 · Edward Weck, Inc. · Ear, Nose, Throat device
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Feb 1984
Decision
116d
Days
Class 2
Risk

K833646 is an FDA 510(k) clearance for the PULSATRON NERVE LOCATOR/STIMULATOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 116 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 Edward Weck, Inc. devices

Submission Details

510(k) Number K833646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date February 10, 1984
Days to Decision 116 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
27d slower than avg
Panel avg: 89d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K833646.
Evala Nerve Stimulator (EPNR002)
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K232888 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023