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)
Oct 16, 2019Xodus Medical Inc
Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
Terminated
GEIK053433
Oct 16, 2019Xodus Medical Inc
Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
Terminated
GEIK053433
Oct 16, 2019Xodus Medical Inc
Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
Terminated
GEIK053433
Oct 2, 2019Angiodynamics 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
GEIK010060
Sep 12, 2019Stryker 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
GEIK934094
Sep 12, 2019Stryker 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
GEIK963765
Aug 19, 2019CooperSurgical, Inc.
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Terminated
GEIK120476
Aug 7, 2019Aesculap 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
GEIK093075
Aug 7, 2019Aesculap 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
GEIK093075
Jul 19, 2019Integra 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
GEIK083895
May 15, 2019Ethicon Endo-Surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Terminated
GEIK172580
May 15, 2019Ethicon Endo-Surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Terminated
GEIK172580
May 15, 2019Ethicon Endo-Surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Terminated
GEIK172580
Mar 22, 2019Microline Surgical, Inc.
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Terminated
GEIK062257
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Terminated
GEIK123429
Mar 8, 2019Gyrus ACMI, Inc.
Olympus Diego Elite Console MDCONS 100
Terminated
GEIK123429
Feb 15, 2019Covidien, 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
GEIK150735
Dec 12, 2018Applied 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
GEIK171684
Aug 31, 2018Terumo 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
GEIK140008
Aug 13, 2018Megadyne Medical Products, Inc.
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
Terminated
GEIK050579
Aug 6, 2018Dannoritzer 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
GEIK052759
Jun 18, 2018Bovie 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
GEIK152570
May 11, 2018Olsen 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
GEIK080187
May 11, 2018Olsen 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
GEIK130669
May 11, 2018Olsen 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
GEIK111262
May 11, 2018Olsen 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
GEIK111262
May 11, 2018Olsen 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
GEIK936304
Apr 23, 2018DeRoyal 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
GEIK940909
Feb 26, 2018Beaver-Visitec International Inc.
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Terminated
GEIK911160
Feb 26, 2018Beaver-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
GEIK911160
Feb 8, 2018Bovie Medical Corporation
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Terminated
GEIK170188
Feb 8, 2018Bovie Medical Corporation
J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Terminated
GEIK170188
Feb 8, 2018Bovie Medical Corporation
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Terminated
GEIK170188
Feb 8, 2018Bovie Medical Corporation
J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Terminated
GEIK170188
Feb 8, 2018Bovie Medical Corporation
J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
Terminated
GEIK170188
Jan 3, 2018Teleflex 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
GEIK153063
Jan 3, 2018Teleflex 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
GEIK153063
Nov 1, 2017Microline 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
GEIK962119
Nov 1, 2017Microline 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
GEIK981389
Oct 18, 2017Teleflex 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
GEIK153063
Jul 19, 2017Teleflex 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
GEIK153063
Jul 19, 2017Teleflex 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
GEIK153063

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