Cannula, Surgical, General & Plastic Surgery
FDA product code GEA · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
36510(k) clearances
0PMA approvals
21recalls
Manufacturers
- Jeff Klein Surgical, Inc. 3
- ETHICON, Inc. 3
- Axiom Medical, Inc. 2
- Wells Johnson Co. 2
- Bowen & Company, Inc. 1
- Pilling Co. 1
- Aesculap, Inc. 1
- American Instrument Manufacturer'S, Inc. 1
- CooperVision, Inc. 1
- American Silk Sutures, Inc. 1
- Apex Medical Corp. 1
- Celebration Medical Products, Inc. 1
- Lifestream Int'L, Inc. 1
- Advanced Biosearch Assn. 1
- Byron Medical 1
- Progress Mankind Technology 1
- Dedo Manufacturer, Inc. 1
- Pennine Medical , Ltd. 1
- Zimmar Consulting , Ltd. 1
- Medicalex 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003965 | MRI Safe InstrumentsGEA · Traditional | Aesculap, Inc. | 03/16/2001SE |
| K982472 | Genicon TrocarGEA · Traditional | Genicon, LC | 02/04/1999SE |
| K954599 | Conmed Trogard Electronic Trocar SystemGEA · Traditional | Conmedcorp | 11/27/1995SE |
| K922460 | Origin Secondary Cannula and TrocarGEA · Traditional | Origin Medsystems, Inc. | 09/16/1992SE |
| K920110 | Endopath Disposable Thoracic Trocar SleeveGEA · Traditional | ETHICON, Inc. | 04/02/1992SE |
| K911262 | Disposable Specimen Bag W/Cannula and IntroducerGEA · Traditional | ETHICON, Inc. | 06/20/1991SE |
| K904881 | Disposable Yankauer Suction TubeGEA · Traditional | Pilling Medical S.A. | 03/06/1991SE |
| K903416 | Cannula, SurgicalGEA · Traditional | Advantage Diagnostics Corp. | 11/23/1990SE |
| K904218 | Suction SystemGEA · Traditional | Axiom Medical, Inc. | 10/31/1990SE |
| K901718 | Klein Lamprey-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
| K901717 | Klein Micro-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
| K901719 | Klein Micro-Cannula Handle(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/22/1990SE |
| K895684 | Soft Suction AdapterGEA · Traditional | Applied Medical Technologies | 11/20/1989SE |
| K896434 | Auto Suture Surgiport Cannula Diameter Reducer*GEA · Traditional | United States Surgical, A Division of Tyco Healthc | 11/16/1989SE |
| K895762 | Canula Suction for Surgical General and PlasticGEA · Traditional | Kolster Methods | 10/18/1989SE |
| K895670 | Surgical Suction ApparatusGEA · Traditional | Baker-Sundt Research, Inc. | 09/27/1989SE |
| K880669 | L-5 Plastic Surgery CannulasGEA · Traditional | American Instrument Manufacturer'S, Inc. | 03/17/1988SE |
| K872214 | Cooper Surg Aspiration Cannula/Custom Conven PaksGEA · Traditional | CooperVision, Inc. | 08/17/1987SE |
| K872906 | Suction Tube Tip Fits Over Bussie Frazier TubeGEA · Traditional | American Silk Sutures, Inc. | 08/11/1987SE |
| K871384 | Apex Suction CuretteGEA · Traditional | Apex Medical, Inc. | 05/22/1987SE |
| K871043 | (I) LV and (II) HV Series CannulaGEA · Traditional | Celebration Medical Products, Inc. | 04/23/1987SN |
| K863293 | Disposable Suction Cannula No. 902008-000GEA · Traditional | Lifestream Int'L, Inc. | 09/09/1986SE |
| K863150 | Bowen CannulaGEA · Traditional | Bowen & Company, Inc. | 09/05/1986SE |
| K862936 | Newman Cannulae System (NCS)GEA · Traditional | Byron Medical | 08/14/1986SN |
| K861306 | Suction SystemGEA · Traditional | Axiom Medical, Inc. | 06/09/1986SE |
| K854005 | Dedo Suction CannulaGEA · Traditional | Dedo Manufacturer, Inc. | 12/06/1985SN |
| K844874 | Pennine Link YankauersGEA · Traditional | Pennine Medical , Ltd. | 06/06/1985SE |
| K843468 | Pharma-Plast Suction Set Type YankauerGEA · Traditional | Zimmar Consulting , Ltd. | 11/23/1984SE |
| K843187 | CannulaGEA · Traditional | ETHICON, Inc. | 10/31/1984SE |
| K833377 | MedicalexGEA · Traditional | Medicalex | 09/27/1984SE |
| K841249 | Suction CannulasGEA · Traditional | Custom Surgical Products, Inc. | 06/04/1984SE |
| K833717 | Padgett Suction CannulaGEA · Traditional | Advanced Biosearch Assn. | 12/14/1983SE |
| K832521 | Plastic Suction TipsGEA · Traditional | Wells Johnson Co. | 10/20/1983SE |
| K832520 | Suction TipsGEA · Traditional | Wells Johnson Co. | 10/20/1983SE |
| K832636 | Frazier Suction Instrument-DisposGEA · Traditional | Pilling Co. | 10/14/1983SE |
| K810627 | Model 1301 Biotac (TM)GEA · Traditional | Progress Mankind Technology | 04/02/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0938-2025 Class II | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-1781-2021 Class II | Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage:…single use devices labeled as sterile may not have been adequately sterilized | Clinical Laserthermia Systems AB | 04/01/2021Terminated |
| Z-1456-2020 Class II | Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid…Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR"… | Cardinal Health 200, LLC | 01/15/2020Terminated |
| Z-1845-2020 Class II | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110…There was incorrect raw material used in the production of the identified lot. | TeDan Surgical Innovations LLC | 07/16/2019Terminated |
| Z-2279-2020 Class II | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2278-2020 Class II | Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2277-2020 Class II | Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2276-2020 Class II | Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2275-2020 Class II | Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2274-2020 Class II | Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2273-2020 Class II | Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2272-2020 Class II | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2271-2020 Class II | Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2270-2020 Class II | Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2269-2020 Class II | Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2268-2020 Class II | Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2267-2020 Class II | Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-2266-2020 Class II | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | Genicon, Inc. | 08/21/2018Open, Classified |
| Z-1816-2016 Class II | Various trauma and sports medicine instruments and implants. cannula, surgical, general…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | Biomet, Inc. | 04/01/2016Terminated |
| Z-1328-2016 Class II | MicroAire PAL Cannula Product Usage - Power Aspiration DeviceMicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to… | MicroAire Surgical Instruments, LLC | 02/08/2016Terminated |
| Z-0622-2009 | Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter…The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and… | Genico, Inc., dba Genicon | 09/25/2008Terminated |