Cleared Traditional

K903416 - CANNULA, SURGICAL

K903416 is an FDA 510(k) clearance for CANNULA, manufactured by Advantage Diagnostics Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K903416 · Advantage Diagnostics Corp. · General & Plastic Surgery device
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Nov 1990
Decision
116d
Days
Class 1
Risk

K903416 is an FDA 510(k) clearance for the CANNULA, SURGICAL. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Advantage Diagnostics Corp. (Tucson, US). The FDA issued a Cleared decision on November 23, 1990 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Advantage Diagnostics Corp. devices

FDA 510(k) Submission Details - K903416

510(k) Number K903416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date November 23, 1990
Days to Decision 116 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 115d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

GEA Device Classification - Class 1, General Controls

Product Code GEA Cannula, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - GEA Cannula, Surgical, General & Plastic Surgery

All 18
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K903416.
ORIGIN SECONDARY CANNULA AND TROCAR
K922460 · Origin Medsystems, Inc. · Sep 1992
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
K920110 · Ethicon, Inc. · Apr 1992
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · Ethicon, Inc. · Jun 1991
SUCTION SYSTEM
K904218 · Axiom Medical, Inc. · Oct 1990
SOFT SUCTION ADAPTER
K895684 · Applied Medical Technologies · Nov 1989
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
K896434 · United States Surgical, A Division of Tyco Healthc · Nov 1989