Cleared Traditional

K982472 - GENICON TROCAR

K982472 is an FDA 510(k) clearance for GENICON TROCAR, manufactured by Genicon, LC. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K982472 · Genicon, LC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
204d
Days
Class 1
Risk

K982472 is an FDA 510(k) clearance for the GENICON TROCAR. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Genicon, LC (Orlando, US). The FDA issued a Cleared decision on February 4, 1999 after a review of 204 days - an extended review 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: 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 Genicon, LC devices

FDA 510(k) Submission Details - K982472

510(k) Number K982472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date February 04, 1999
Days to Decision 204 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 115d · This submission: 204d
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 17
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K982472.
MRI SAFE INSTRUMENTS
K003965 · Aesculap, Inc. · Mar 2001
CONMED TROGARD ELECTRONIC TROCAR SYSTEM
K954599 · Conmedcorp · Nov 1995
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