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510(k) Data Aggregation
K Number
K180766Device Name
Endiscope, Endiscope Cervical
Manufacturer
Elliquence, LLC
Date Cleared
2018-06-11
(80 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Elliquence, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Elliquence endoscopes are indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.
Device Description
The Endiscope is an optical and fiber optic based rigid endoscope available with working channels of 2.8 mm, 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy.
The Endiscope Cervical is an optical and fiber optic-based rigid endoscope available with a working channel of 2.2 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine.
Elliquence endoscopes may be attached to standard fiber optic light sources, commonly available video adapters and cameras such as Storz, Olympus and Wolf.
The devices are reusable, delivered in non-sterile conditions and available in various designs:
- Outer Diameters from 3.6 mm to 7.0 mm
- Diameter of working channel from 2.2 mm to 4.3 mm
- Working length from 95 mm to 208 mm
- Direction of view: 0%6° (Endiscope Cervical), 30° (Endiscope)
- Viewing angle 80° +/- 5°
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K Number
K170107Device Name
Surgi Max Ultra
Manufacturer
elliquence, LLC
Date Cleared
2017-05-03
(111 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
elliquence, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthopedic, arthroscopic, spinal, and neurological
For resection, ablation, and coagulation of soft tissues and hemostasis in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation 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 flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinage, 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, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
Device Description
The elliquence Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is a modification to the existing Surgi-Max® / Surgi-Max® Plus (K100390) line of radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. It is designed to enable the performance of monopolar and bipolar functions in conjunction with separatelymarketed electrosurgical accessories and ancillary equipment which have been developed by elliquence for mutually-exclusive use with the Surgi-Max® line of generators.
The Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is the result of an update to internal electrical components of the Surgi-Max® / Surgi-Max® Plus. As a result of this equipment update, device design as it relates to internal electrical system framework was simplified in many respects and overall efficiency was greatly improved upon. This increase in efficiency enabled an increase in the maximum power output of the device from 120W to 170W. Aside from this increase in maximum power output, all other operational aspects of the device were conserved. The only other modifications made to the device were aesthetic in nature.
The modifications enacted do not affect the device's intended use or alter its fundamental scientific technology.
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