Cleared Traditional

ENDEX ENDOSCOPIC POSITIONING SYSTEM (K936308) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K936308 · Andronic Devices, Ltd. · General & Plastic Surgery device
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Mar 1994
Decision
101d
Days
Class 1
Risk

K936308 is an FDA 510(k) clearance for the ENDEX ENDOSCOPIC POSITIONING SYSTEM. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Andronic Devices, Ltd. (Richmond, B.C. Canada V6v 2j2, CA). The FDA issued a Cleared decision on March 31, 1994 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Andronic Devices, Ltd. devices

Submission Details

510(k) Number K936308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date March 31, 1994
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQO Table, Operating-room, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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.