GENICON TROCAR— 510(k) K982472

Name: FDA 510(k) clearance K982472
Creator: U.S. Food and Drug Administration
Published: 1999-02-04

Substantially Equivalent

Genicon, LC

FDA 510(k) clearance K982472 for GENICON TROCAR, Substantially Equivalent on 1999-02-04. Applicant: Genicon, LC. Device class: 1.

Clearance details

Applicant: Genicon, LC
Product code: Code GEA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1998-07-15
Decision date: 1999-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEA

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K003965 — MRI SAFE INSTRUMENTS2001-03-16
K954599 — CONMED TROGARD ELECTRONIC TROCAR SYSTEM1995-11-27
K922460 — ORIGIN SECONDARY CANNULA AND TROCAR1992-09-16
K920110 — ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE1992-04-02
K911262 — DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER1991-06-20

More clearances from Genicon, LC

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K030174 — GENICON LAPAROSCOPES2003-06-19
K030269 — GENICON CLIP APPLIER2003-03-20
K002542 — REUSABLE CANNULA2000-10-23
K993625 — INSUFFLATION NEEDLE- 120MM, MODEL 900-2002000-06-20
K991382 — SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-1011999-07-15

Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K982472

K-number listed on FDA's recall record

Z-2266-2020 — Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2267-2020 — Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2268-2020 — Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2269-2020 — Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2270-2020 — Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2271-2020 — Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2272-2020 — Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2273-2020 — Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2274-2020 — Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2275-2020 — Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2276-2020 — Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2277-2020 — Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2278-2020 — Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821
Z-2279-2020 — Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.Class II·Ongoing·Genicon, Inc.·20180821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982472.

Data sourced from openFDA. This site is unofficial and independent of the FDA.