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) |
|---|---|---|---|
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 28, 2012 | Unimed 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 |
GEI | K944265 K962935 |
| Aug 3, 2012 | Smith & 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 |
GEI | K012314 |
| Aug 3, 2012 | Smith & 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 |
GEI | K012314 |
| Jul 13, 2012 | Stingray 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 |
GEI | K083162 |
| Jul 12, 2012 | PSC 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 |
GEI | K885199 |
| Jul 12, 2012 | PSC 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 |
GEI | K885199 |
| Jul 12, 2012 | PSC 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 |
GEI | K885199 |
| Jul 12, 2012 | PSC 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 |
GEI | K884656 |
| Jul 12, 2012 | PSC 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 |
GEI | K982705 |
| Jul 12, 2012 | PSC 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 |
GEI | K885199 |
| Jul 11, 2012 | PSC 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 |
GEI | K936304 |
| Jul 11, 2012 | PSC 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 |
GEI | K936304 |
| Jul 9, 2012 | Stryker 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 |
GEI | K935237 |
| Jul 6, 2012 | Encision, 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 |
GEI | K091074 |
| Jun 11, 2012 | Plasma 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 |
GEI | K080197 |
| May 29, 2012 | ConMed 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 |
GEI | K101534 |
| May 29, 2012 | ConMed 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 |
GEI | K101534 |
| May 29, 2012 | ConMed 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 |
GEI | K101534 |
| May 29, 2012 | ConMed 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 |
GEI | K101534 |
| May 29, 2012 | ConMed 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 |
GEI | K101534 |
| May 17, 2012 | Ellman 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 |
GEI | K082834 |
| Mar 28, 2012 | Boston 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 |
GEI | K053128 |
| Mar 21, 2012 | Ethicon 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 |
GEI | K112033 |
| Mar 13, 2012 | Stryker 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 |
GEI | K012695 |
| Jan 13, 2012 | Olympus 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 |
GEI | K073207 |
| Jan 11, 2012 | Covidien, 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 |
GEI | K031011 |
| Jan 11, 2012 | Covidien, 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 |
GEI | K031011 |
| Jan 11, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector
Catalog Number: 7205962. Terminated |
GEI | K012314 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand Terminated |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech 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 |
GEI | K082980 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. 3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand Terminated |
GEI | K082980 |
| Nov 21, 2011 | Stryker Endoscopy Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300; Terminated |
GEI | K071859 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.