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510(k) Data Aggregation
K Number
K233425Device Name
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
Manufacturer
Sutter Medizintechnik GmbH
Date Cleared
2024-01-25
(106 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Sutter Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current.
The products are intended for use in endoscopically performed or supported surgeries.
The types of surgery intended are:
- Endoscopic procedures
- Orthopedic procedures
- Neurosurgical coagulation
Device Description
FlexTip Bipolar electrodes single-use consist of a handpiece with electrode front part, cable and plug. The Bipolar electrodes are available in two different working lengths. The FlexTip electrodes are encoded for RF generators Arthrex Inc. (AR-S9800 Synergy) and Sutter Medizintechnik GmbH (K171869 CURIS® RF Generator). The electrodes are provided sterile and are single-use instruments. Electrode shaft and tips are made of stainless steel and are insulated with PEBAX tubing.
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K Number
K193587Device Name
Sutter Swyng non-stick bipolar forceps, single-use
Manufacturer
Sutter Medizintechnik GmbH
Date Cleared
2020-02-10
(49 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Sutter Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue.
Device Description
Sutter Swyng® non-stick bipolar forceps, single-use are electrosurgical instruments. The bipolar forceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.
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K Number
K192128Device Name
Sutter Arrowtip Monopolar Electrodes
Manufacturer
Sutter Medizintechnik GmbH
Date Cleared
2019-10-04
(58 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Sutter Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARROWtip™ Single-Use monopolar electrosurgical instrument for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The ARROWtip™ Single-Use monopolar electrode is not intended for use in the central nervous system or in the central circulatory system.
Device Description
Sutter ARROW tip™ Monopolar Electrodes are electrosurgical instruments. The electrodes are provided with different angled electrode front parts and in different lengths. They are to be connected through an appropriate monopolar handpiece with the monopolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.
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K Number
K191732Device Name
Sutter RaVoR Bipolar Electrodes
Manufacturer
Sutter Medizintechnik GmbH
Date Cleared
2019-08-30
(63 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Sutter Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery.
The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring.
The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.
Device Description
Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments available in different angled sheath configurations. They are to be connected to the bipolar output of the Sutter CURIS® RF Generator. The electrodes are provided sterile and are single-use devices.
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K Number
K171869Device Name
Sutter CURIS RF Generator
Manufacturer
Sutter Medizintechnik GmbH
Date Cleared
2018-02-23
(246 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Sutter Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sutter CURIS® RF Generator is intended for:
Orthopedic, arthroscopic, spinal and neurosurgical:
For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures
For soft tissue resection and coaqulation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist
Cutting:
Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin tags, Blepharoplasty
Blended Cutting and Coagulation:
Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal cell carcinoma, Nevi, Fistulas, Epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps
Hemostasis and nonablative Coagulation:
Control of bleeding, Epilation, Teleangiectasia
Bipolar:
Pinpoint. Precise Coagulation. Pinpoint Hemostasis in any field (wet or dry), snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage
Contraindications:
This device is not intended for vessel sealing.
Device Description
The Sutter CURIS® RF Generator is a compact source of high radiofrequency RF energy to be employed for a variety of electrosurqical procedures. This is achieved by the selection of different wave forms and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Lamps give the operator feedback on the status.
The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through foot switch and/or hand switch. Monopolar and bipolar electrodes are available for use.
The maximum power output of the device in CUT mode is 100 watts (at 400 Ohms load), and 80 watts maximum in COAG mode at 50 Ohms. Operating frequency of the device is maintained at 4.0 MHz.
The device offers both monopolar and bipolar output wave forms. In monopolar mode it offers two CUT wave forms and two COAG wave forms. In bipolar mode it offers three CUT wave forms and three COAG wave forms.
The Sutter CURIS® RF Generator is packaged together with power cord and instruction manual. Optional accessories are a foot switch with cable and appropriate monopolar and bipolar cables.
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K Number
K150959Device Name
Sutter Bipolar Forceps-Calvian
Manufacturer
SUTTER MEDIZINTECHNIK GMBH
Date Cleared
2015-09-10
(153 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SUTTER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: Sutter Bipolar Forceps - Calvian are intended to remove tissue and control bleeding.
Device Description
Sutter Bipolar Forceps - Calvian is an electrosurgical tool available in different handle styles and tip sizes. It is constructed with medical grade stainless steel, coated with Polyamide PA 11 as electrical insulator and possesses tips made of stainless steel that are partly not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is intended to remove tissue and control bleeding. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.
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K Number
K131012Device Name
SUTTER BIPOLAR FORCEPS - SUPERGLISS
Manufacturer
SUTTER MEDIZINTECHNIK GMBH
Date Cleared
2013-08-23
(134 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SUTTER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation.
Indications: General surgery, Orthopaedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynaecological coagulation (except for use in female sterilisation), Urological coagulation, Ear-, Nose- and Throat coagulation.
Device Description
Sutter Bipolar Forceps - SuperGliss is an electrosurgical tool in tweezers configuration with differences in tip size and branches styles. It is constructed with medical grade stainless steel (branches), coated with Polyamid PA 11 as electrical insulator and possesses a tip made of silver alloy that is not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is designed to grasp, manipulate and coagulate selected tissue. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.
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K Number
K073450Device Name
SUTTER ELECTROSURGICAL CABLES
Manufacturer
SUTTER MEDIZINTECHNIK GMBH
Date Cleared
2008-03-17
(98 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SUTTER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.
Device Description
Sutter Electrosurgical Cables are electrosurgical accessories designed to transfer electrosurgical power to monopolar and bipolar instruments from an electrosurgical generator. The cables are designed to fit standard monopolar/bipolar instruments and generator connectors. Sutter Electrosurgical Cables are supplied non-sterile, and can be reused after cleaning and steam sterilization.
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