Cleared Traditional

K873964 - NICOLET DISPOSABLE PRASS PROBE

K873964 is the FDA 510(k) clearance for NICOLET DISPOSABLE PRASS PROBE by Nicolet Biomedical Instruments. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K873964 · Nicolet Biomedical Instruments · Ear, Nose, Throat device
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Nov 1987
Decision
52d
Days
Class 2
Risk

K873964 is an FDA 510(k) clearance for the NICOLET DISPOSABLE PRASS PROBE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Madison, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 52 days - a notably fast clearance 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: 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 Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K873964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1987
Decision Date November 20, 1987
Days to Decision 52 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
37d faster than avg
Panel avg: 89d · This submission: 52d
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 39
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K873964.
NERVE LOCATOR/STIMULATOR
K905045 · Aaron Medical Industries · Mar 1991
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MONTGOMERY NERVE STIMULATOR
K880720 · Boston Medical Products, Inc. · May 1988
MODEL 6110C OTOPHOR
K870272 · Life-Tech Intl., Inc. · Aug 1987
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · Edward Weck, Inc. · Feb 1984
NERVE LOCATER/STIMULATOR
K781569 · Intermedics, Inc. · Dec 1978