Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
47510(k)s in 12 months (2,321 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
Top companies in GEI
| Company | 510(k)s | Recalls |
|---|---|---|
| ArthroCare Corporation | 86 | 5 |
| Conmed Corporation | 25 | 53 |
| Valleylab | 69 | 0 |
| Megadyne Medical Products, Inc. | 32 | 31 |
| Covidien | 41 | 14 |
| Carefusion 2200, Inc. | 2 | 45 |
| Stryker | 9 | 35 |
| Conmedcorp | 43 | 0 |
| Gyrus Acmi, Inc. | 21 | 20 |
| Bovie Medical | 21 | 15 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2019 | Xodus Medical Inc Cautery Tip Cleaner
REF: 30500
Product Usage: electrosurgical accessory Terminated |
GEI | K053433 |
| Oct 16, 2019 | Xodus Medical Inc Electrosurgical Tip Cleaner
REF: 62-8499-001
Product Usage: electrosurgical accessory Terminated |
GEI | K053433 |
| Oct 16, 2019 | Xodus Medical Inc Electrosurgical Tip Cleaner
REF: 138029
Product Usage: electrosurgical accessory Terminated |
GEI | K053433 |
| Oct 2, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 Terminated |
GEI | K010060 |
| Sep 12, 2019 | Stryker Corporation Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926
This products was distributed with the following sheath/probe:
0250 Terminated |
GEI | K934094 |
| Sep 12, 2019 | Stryker Corporation Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971
These products are distributed with the following sheath/probe:
025 Terminated |
GEI | K963765 |
| Aug 19, 2019 | CooperSurgical, Inc. LEEP Return Patient Pads (10/ box)
Model # 6050Pl
used in electrosurgical procedures. Terminated |
GEI | K120476 |
| Aug 7, 2019 | Aesculap Implant Systems LLC CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM
REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired. Terminated |
GEI | K093075 |
| Aug 7, 2019 | Aesculap Implant Systems LLC CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired. Terminated |
GEI | K093075 |
| Jul 19, 2019 | Integra LifeSciences Corp. Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plas Terminated |
GEI | K083895 |
| May 15, 2019 | Ethicon Endo-Surgery Inc Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft
PRODUCT CODE: NSLX145C Terminated |
GEI | K172580 |
| May 15, 2019 | Ethicon Endo-Surgery Inc Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft
PRODUCT CODE: NSLX137C Terminated |
GEI | K172580 |
| May 15, 2019 | Ethicon Endo-Surgery Inc Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft
PRODUCT CODE: NSLX125C Terminated |
GEI | K172580 |
| Mar 22, 2019 | Microline Surgical, Inc. TLS2 Thermal Ligating Shears, Catalog Number 132-131D Terminated |
GEI | K062257 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Malleable, 4mm Standard Monopolar Blades
Product Code:MM4000SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Blades Monopolar, 4mm Straight, TIA
Product Code:MB4000SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number: BB4040XC Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number: BB4040SC Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number:BB4040SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm straight,
Part No: BB4000SC Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm straight,
Part Number: BB4000SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A
Part No BB2000SA Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Olympus Diego Elite Console
MDCONS 100 Terminated |
GEI | K123429 |
| Feb 15, 2019 | Covidien, PLC Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue.
Product Usage:
Single-use device intended for use in open procedures (such a Terminated |
GEI | K150735 |
| Dec 12, 2018 | Applied Medical Resources Corp Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm
REF CW002 QTY: 1 - Product Usage:
The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy Terminated |
GEI | K171684 |
| Aug 31, 2018 | Terumo Cardiovascular Systems Corporation VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX
Product Usage:
The VittuoSaph Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasiv Terminated |
GEI | K140008 |
| Aug 13, 2018 | Megadyne Medical Products, Inc. MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 Terminated |
GEI | K050579 |
| Aug 6, 2018 | Dannoritzer Medizintechnik GmbH & Co. KG Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, Terminated |
GEI | K052759 |
| Jun 18, 2018 | Bovie Medical Corporation J-Plasma Precise 360, single use, disposable.
The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open Terminated |
GEI | K152570 |
| May 11, 2018 | Olsen Medical Symmetry Olsen monopolar forceps:
(a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10
(b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QT Terminated |
GEI | K080187 |
| May 11, 2018 | Olsen Medical Symmetry Olsen bipolar forceps:
(a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5
(b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm T Terminated |
GEI | K130669 |
| May 11, 2018 | Olsen Medical Symmetry Olsen monopolar cord:
(a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50
(b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10
(c) Mo Terminated |
GEI | K111262 |
| May 11, 2018 | Olsen Medical Symmetry Olsen bipolar cord:
(a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50
(b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10
Terminated |
GEI | K111262 |
| May 11, 2018 | Olsen Medical Symmetry Olsen Monopolar Pencil:
(a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50
(b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50
(c) Rocker Switchpen, w/ Stan Terminated |
GEI | K936304 |
| Apr 23, 2018 | DeRoyal Industries Inc DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502
Product Usage: general surgical Terminated |
GEI | K940909 |
| Feb 26, 2018 | Beaver-Visitec International Inc. Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549 Terminated |
GEI | K911160 |
| Feb 26, 2018 | Beaver-Visitec International Inc. WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270.
Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedu Terminated |
GEI | K911160 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF Terminated |
GEI | K170188 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR Terminated |
GEI | K170188 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B Terminated |
GEI | K170188 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N Terminated |
GEI | K170188 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS Terminated |
GEI | K170188 |
| Jan 3, 2018 | Teleflex Medical Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the a Terminated |
GEI | K153063 |
| Jan 3, 2018 | Teleflex Medical Percuvance(R) Percutaneous Shaft 29cm, PCVSH3
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the ab Terminated |
GEI | K153063 |
| Nov 1, 2017 | Microline Surgical, Inc. ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115
The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indica Terminated |
GEI | K962119 |
| Nov 1, 2017 | Microline Surgical, Inc. ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989
The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are Terminated |
GEI | K981389 |
| Oct 18, 2017 | Teleflex Medical Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components:
(a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5
(b) 5 mm Maryland Dissector, Catalog Number PCVMD5
(c) 5 mm Hem-o-lok Terminated |
GEI | K153063 |
| Jul 19, 2017 | Teleflex Medical Percuvance 29cm Shaft
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, m Terminated |
GEI | K153063 |
| Jul 19, 2017 | Teleflex Medical Percuvance Scissors Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to g Terminated |
GEI | K153063 |
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