Panels › General, Plastic Surgery › Product code GEA · Class 1
Cannula, Surgical, General & Plastic Surgery
Regulation 878.4800
0510(k)s in 12 months (36 all time)
0recalls in 12 months (24 all time)
15recalls that name a 510(k)
Top companies in GEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Genicon, Inc. | 0 | 14 |
| ETHICON, Inc. | 3 | 0 |
| Jeff Klein Surgical, Inc. | 3 | 0 |
| Axiom Medical, Inc. | 2 | 0 |
| Surgical Specialties Corp | 0 | 2 |
| Wells Johnson Co. | 2 | 0 |
| Advanced Biosearch Assn. | 1 | 0 |
| Advantage Diagnostics Corp. | 1 | 0 |
| Aesculap, Inc. | 1 | 0 |
| American Instrument Manufacturer'S, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176;
2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177;
3) EC Open, Classified |
GEA | None listed |
| Apr 1, 2021 | CLINICAL LASERTHERMIA SYSTEMS AB Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissu Terminated |
GEA | None listed |
| Jan 15, 2020 | Cardinal Health 200, LLC Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules a Terminated |
GEA | None listed |
| Jul 16, 2019 | TeDan Surgical Innovations LLC Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for Terminated |
GEA | None listed |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 usi Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 sco Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 usi Open, Classified |
GEA | K982472 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
cannula, surgical, general & plastic surgery and accessories Terminated |
GEA | None listed |
| Feb 8, 2016 | MicroAire Surgical Instruments, LLC MicroAire PAL Cannula
Product Usage - Power Aspiration Device Terminated |
GEA | None listed |
| Dec 24, 2008 | Genico, Inc., dba Genicon Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002.
Used for incisions made for positioning Terminated |
GEA | K982472 |
| Jul 22, 2005 | ArthroCare Corporation ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905. Terminated |
GEA | None listed |
| Feb 5, 2003 | Surgical Specialties Corp 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End Terminated |
GEA | None listed |
| Feb 5, 2003 | Surgical Specialties Corp 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End Terminated |
GEA | None listed |
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