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510(k) Data Aggregation
K Number
K191479Device Name
Velocity Alpha Highspeed Surgical Drill System
Manufacturer
adeor Medical AG
Date Cleared
2021-04-11
(677 days)
Product Code
HBE
Regulation Number
882.4310Why did this record match?
Applicant Name (Manufacturer) :
adeor Medical AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Velocity Alpha™ Drill System is indicated for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials.
Applications: Cutting, removing, shaping and sawing hard and soft tissue, bone, and bone replacement materials.
Areas of use: Neurosurgery and spinal surgery.
Device Description
The Velocity Alpha™ Highspeed Surgical Drill System is an electric AC powered surgical motor drill system for rapid cutting, sawing, drilling and manipulation of soft tissue and bone.
The Subject Device has several components, such as an electric motor hand piece connected to and driven by an AC-powered control unit, a foot control unit (wired or wireless (Bluetooth)) and several adapters and nosepiece attachments, e.g. straight & angled nosepiece attachments, craniotome attachments, speed reducer attachments and sawing attachments.
The device has an optional irrigation pump that can supply irrigation through sterile tubing. Speed is variable from 1.000 RPM up to 80.000 RPM in order to adjust the speed to the surgeon's requirements. The direction of rotation can be pre-selected to the left and to the right.
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K Number
K191847Device Name
Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps
Manufacturer
Adeor Medical AG
Date Cleared
2020-05-22
(317 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Adeor Medical AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp.
The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
The types of surgery intended include:
- ENT
- Gynecology (except for use in female sterilization)
- Urology
- General surgery
- Neurosurgery
- Laryngeal Surgery
- Orthopedic Surgery
- Thoracic Surgery
Device Description
The Adeor Medical AG Bipolar Forceps are electrosurgical instruments used to grasp, manipulate, cut or coagulate tissue. Bipolar forceps have various lengths and tip configurations, as well as irrigation and suction technologies. Both reusable and single-use forceps are available, with flat plug or two pin plug configurations. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of a high frequency generator and may be used only with bipolar coagulation current. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz: maximum generator operating voltage 600Vn.
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K Number
K130755Device Name
HICUT HIGHSPEED INSTRUMENT
Manufacturer
ADEOR MEDICAL AG
Date Cleared
2014-06-27
(465 days)
Product Code
HBE
Regulation Number
882.4310Why did this record match?
Applicant Name (Manufacturer) :
ADEOR MEDICAL AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HiCut™ Highspeed Instruments are surgical burs indicated for trephination, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and biomaterials in Orthopedic Surgery, Neurological and Spinal Surgery, Plastic and Maxillofacial Surgery, Arthroscopy, Sternotomy and General Surgery.
Device Description
The HiCut™ Highspeed Instrument is a sterile packed, single-use cutting device with numerous tip designs and various lengths. The rear end is designed to fit in various commonly marketed surgical motor drill systems. The tip designs are similar to the commonly used tip designs.
The HiCut™ Highspeed Instrument is classified Class II (USA) (Class IIa in EU) per CFR, Part 882.4310. The HiCut™ Highspeed Instruments are simple powered burs to be inserted in pneumatic or electric powered motor drill devices.
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