Cleared Traditional

K945876 - WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K945876 · Wells Johnson Co. · Ear, Nose, Throat device
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Dec 1995
Decision
368d
Days
Class 1
Risk

K945876 is an FDA 510(k) clearance for the WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on December 4, 1995 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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. Elevated predicate reliance profile. 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 Wells Johnson Co. devices

Submission Details

510(k) Number K945876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date December 04, 1995
Days to Decision 368 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 89d · This submission: 368d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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.