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510(k) Data Aggregation
K Number
K092977Device Name
EBERLE SHAVER SYSTEM ACCESSORIES
Manufacturer
Date Cleared
2010-09-29
(369 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
EFS EBERLE FEINWERKTECHNISCHE SYSTEME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EBERLE Shaver System Accessories are designed to use with the EBERLE Shaver System for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.
Device Description
The Eberle Shaver System Accessories are manufactured by EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG in Germany. They are developed for surgical use in the field of arthroscopy and should only be used by trained personnel in designated institutions.
The Eberle Single Use Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector consist of POM, the tubes consists of stainless steel. The Blades are provided in a sterile packaging and are intended for single use (not autoclave- reusable).
The Eberle Hand Piece with Switch has three buttons to select the direction of rotation. It consists of Stainless Steel and Aluminum.
The Eberle Drill- and the Saw- Hand Piece also consist of Stainless Steel and Aluminum. The Drill has two buttons to select the direction of rotation and the Saw hast a operator lever.
All these components are designed, constructed and intended to be operated exclusively as a unit with the Eberle Shaver System C2.
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K Number
K061134Device Name
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
Manufacturer
Date Cleared
2006-09-01
(130 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
EFS EBERLE FEINWERKTECHNISCHE SYSTEME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EBERLE Shaver System C2 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.
Device Description
The EBERLE Shaver System is a powered surgical instrument system and consists of a control unit, a footswitch, a handpiece and associated shaver blades (autoclavereusable, sterile/ non-sterile). All these components are designed, constructed and intended to be operated exclusively as a unit.
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