Cleared Traditional

K933798 - NU-PREP GEL

K933798 is an FDA 510(k) clearance for NU-PREP GEL, manufactured by Cadwell Laboratories, Inc.. The device is a Class 1 Neurology device with product code GXB cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K933798 · Cadwell Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
261d
Days
Class 1
Risk

K933798 is an FDA 510(k) clearance for the NU-PREP GEL. Classified as Esthesiometer (product code GXB), Class I - General Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on April 22, 1994 after a review of 261 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1500 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K933798

510(k) Number K933798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date April 22, 1994
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 148d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

GXB Device Classification - Class 1, General Controls

Product Code GXB Esthesiometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.