ClearanceBrief
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)
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Top companies in GEI

DateFirm and productCodeLinked 510(k)
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STER
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STER
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.co
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STE
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STE
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***S
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.co
Terminated
GEIK944265
K962935
Aug 28, 2012Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufa
Terminated
GEIK944265
K962935
Aug 3, 2012Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of l
Terminated
GEIK012314
Aug 3, 2012Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical
Terminated
GEIK012314
Jul 13, 2012Stingray Surgical Products, LLC
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp,
Terminated
GEIK083162
Jul 12, 2012PSC Industries Inc
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek
Terminated
GEIK885199
Jul 12, 2012PSC Industries Inc
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek pee
Terminated
GEIK885199
Jul 12, 2012PSC Industries Inc
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Ty
Terminated
GEIK885199
Jul 12, 2012PSC Industries Inc
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel
Terminated
GEIK884656
Jul 12, 2012PSC Industries Inc
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Mono
Terminated
GEIK982705
Jul 12, 2012PSC Industries Inc
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Ol
Terminated
GEIK885199
Jul 11, 2012PSC Industries Inc
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyv
Terminated
GEIK936304
Jul 11, 2012PSC Industries Inc
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pou
Terminated
GEIK936304
Jul 9, 2012Stryker Endoscopy
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and H
Terminated
GEIK935237
Jul 6, 2012Encision, Inc.
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection an
Terminated
GEIK091074
Jun 11, 2012Plasma Surgical Inc.
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open sur
Terminated
GEIK080197
May 29, 2012ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 10 mm O.D., 23 cm Shaft, Catalog Number 60-9511-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy sourc
Terminated
GEIK101534
May 29, 2012ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source
Terminated
GEIK101534
May 29, 2012ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 23 cm Shaft, Catalog Number 60-9521-001, Sterile/ EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy sourc
Terminated
GEIK101534
May 29, 2012ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog Number 60-9522-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source
Terminated
GEIK101534
May 29, 2012ConMed Electrosurgery
Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS GmbH, Germany. The Altrus Thermal Tissue Fusion System is comprised of a ded
Terminated
GEIK101534
May 17, 2012Ellman International, Inc.
Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablati
Terminated
GEIK082834
Mar 28, 2012Boston Scientific Corporation
Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. The Soloist Needle Electrode is intend
Terminated
GEIK053128
Mar 21, 2012Ethicon Endo-Surgery Inc
ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Curved Jaw, Model # NSLG2C25. Ethicon Endo-Surgery, LLC Guaynabo
Terminated
GEIK112033
Mar 13, 2012Stryker Sustainability Solutions, Inc.
The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic
Terminated
GEIK012695
Jan 13, 2012Olympus America Inc.
Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures duri
Terminated
GEIK073207
Jan 11, 2012Covidien, PLC
LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Covidien Medical Produc
Terminated
GEIK031011
Jan 11, 2012Covidien, PLC
LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Pro
Terminated
GEIK031011
Jan 11, 2012Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
Terminated
GEIK012314
Jan 11, 2012Innovatech Medical Resources L.P.
3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels.
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic p
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic pr
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
3.5mm 90 Degree Part Number A1335-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedu
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
CoVac 70 Product Number AS3730-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in arthroscopic procedures.
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
CoVac 50 Product Number AS2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
MultiVac Tristar 50 Product Number AS4630-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic proce
Terminated
GEIK082980
Jan 11, 2012Innovatech Medical Resources L.P.
3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand
Terminated
GEIK082980
Nov 21, 2011Stryker Endoscopy
Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;
Terminated
GEIK071859

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