Cleared Traditional

EOS BRAND DISPOSABLE PROCTOSCOPE (K954614) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954614 · North Eos Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
188d
Days
Class 2
Risk

K954614 is an FDA 510(k) clearance for the EOS BRAND DISPOSABLE PROCTOSCOPE. Classified as Endoscope, Ac-powered And Accessories (product code GCP), Class II - Special Controls.

Submitted by North Eos Industries, Inc. (Taichung Hsien 423, TW). The FDA issued a Cleared decision on April 10, 1996 after a review of 188 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all North Eos Industries, Inc. devices

Submission Details

510(k) Number K954614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1995
Decision Date April 10, 1996
Days to Decision 188 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 130d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCP Endoscope, Ac-powered And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.