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Found 15 results
510(k) Data Aggregation
K Number
K013255Device Name
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
Manufacturer
ELLMAN INTL., INC.
Date Cleared
2001-11-07
(40 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
* 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 Flaps, SkinTags, 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 CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,
* Hemostasis
Control of Bleeding, Epilation, Telangiectasia
* Fulguration
Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
* 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
Device Description
The @Wman Surgitron 120 IEC enhanced capability Electrosurgery Generator described herein is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. It is designed to comply with international safety standards.
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K Number
K003126Device Name
BIPOLAR TRIGGER-FLEX PROBE
Manufacturer
ELLMAN INTL., INC.
Date Cleared
2001-04-11
(188 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001986Device Name
SURGITRON IEC II
Manufacturer
ELLMAN INTL., INC.
Date Cleared
2000-09-27
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001407Device Name
SURGITRON IEC II
Manufacturer
ELLMAN INTL., INC.
Date Cleared
2000-07-24
(81 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001253Device Name
SURGITRON IEC II
Manufacturer
ELLMAN INTL., INC.
Date Cleared
2000-05-26
(37 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992382Device Name
SURGITRON RADIOLASE
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1999-10-14
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cutting: Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeeurotic Repair, Levator Resection, Arthroscopic Procedures.
Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.
Hemostasis: Control of Bleeding, Epilation, Telangiectasia
Device Description
Surgitron Radiolase is a high frequency, medium power output electrosurgical device. The design is unique, simple, energy efficiency, safe, and user friendly. Furthermore, it equips the essential operational modes that are most often used in electrosurgical application. The unit has a maximum 50 watt output power and provides the capability of precision cutting, coagulating, and hemostasis in four megacycle frequency electrical current. It is designed to comply with international safety standards.
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K Number
K990146Device Name
SURGITRON
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1999-03-17
(57 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
is idendical to the Surgitron as a preammendment device such as:
- * 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 Flaps, SkinTags, 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 CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,
- * Hemostasis Control of Bleeding, Epilation, Telangiectasia
- * Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
- * 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
Device Description
Not Found
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K Number
K980177Device Name
SUGITRON MODEL: IEC
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1998-07-07
(168 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
is idendical to the Surgitron as a preammendment device such as:
* Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.
* Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.
- * Hemostasis Control of Bleeding, Epilation, Telangiectasia
- * Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
- * Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).
Device Description
Not Found
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K Number
K980170Device Name
SURGITRON
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1998-06-29
(160 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
is idendical to the Surgitron as a preammendment device such as:
* Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.
* Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.
- * Hemostasis Control of Bleeding, Epilation, Telangiectasia
- * Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
- * Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).
Device Description
Not Found
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K Number
K972072Device Name
SURGITRON MODEL FFPF-EMC
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1997-06-19
(16 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLMAN INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication For Use is idendical to the Surgitron as a preammendment device such as:
* Culling
Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. SkinTags, Envi, Keratusis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection.
* Blended Curring and Coagulation Skin Tags, Papilloma Kelvido, Keratosis, Verrucac, Dasal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmenc Repairs, Cysts, Absecsses, Development of Skin Flaps, Oculoplastic Procedures
* Ilemostasıs Control of Blocding, Epilation, Telangectasia
* Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Vernicae, Hemostasis.
* Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).
Device Description
Not Found
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