Cleared Traditional

K954599 - CONMED TROGARD ELECTRONIC TROCAR SYSTEM

K954599 is an FDA 510(k) clearance for CONMED TROGARD ELECTRONIC TROCAR SYSTEM, manufactured by Conmedcorp. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K954599 · Conmedcorp · General & Plastic Surgery device
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Nov 1995
Decision
55d
Days
Class 1
Risk

K954599 is an FDA 510(k) clearance for the CONMED TROGARD ELECTRONIC TROCAR SYSTEM. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on November 27, 1995 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conmedcorp devices

FDA 510(k) Submission Details - K954599

510(k) Number K954599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1995
Decision Date November 27, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
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 14
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K954599.
MRI SAFE INSTRUMENTS
K003965 · Aesculap, Inc. · Mar 2001
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