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510(k) Data Aggregation
K Number
K113062Device Name
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
Manufacturer
ENDOSERVICE OPTICAL INSTRUMENTS GMBH
Date Cleared
2012-08-21
(312 days)
Product Code
FBP
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ENDOSERVICE OPTICAL INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing).
Device Description
Endoservice Endoscopic Instruments & Accessories are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility. The urological-gastroenterological accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue, body cavities, hollow organs and canals (grasping, cutting, dissecting, coagulating and suturing). The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive gastrointestinal GI and genitourinary GU Devices contain different components such as Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Forceps, Scissors, Punches, Tubes, Trocars, Trocar Sleeves, Sheat, Needle holder, and Inserts. The device is made out of following materials: Body: steel 1.4301; plastic PPSU Handle: adhesive hysol-resin Lens: saphir
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