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510(k) Data Aggregation
K Number
K200770Device Name
Mini PCNL-System
Manufacturer
Trokamed GmbH
Date Cleared
2021-07-30
(492 days)
Product Code
FED, MIN
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Trokamed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site. The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.
Device Description
The TROKAMED GmbH Mini PCNL-System consists of shaft and dilator. The diameter is specified directly on the shaft and dilator. This ensures that the instrument can be assigned easily and only suitable components are used. The instruments cannot be disassembled. The puncture is expanded with the dilator at the beginning of surgery. The procedure, during which kidney stones can be destroyed, is then performed via the shaft. The kidney stones are automatically transported out of the proximal end of the shaft as a result of the cleaning pressure and by the irrigation fluid. The nephroscope may not be fully mounted on the shaft here.
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K Number
K091010Device Name
TROKAMED MORCELLATOR
Manufacturer
TROKAMED GMBH
Date Cleared
2011-03-01
(691 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
TROKAMED GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
Device Description
The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps.
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K Number
K060233Device Name
TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
Manufacturer
TROKAMED GMBH
Date Cleared
2006-07-19
(170 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
TROKAMED GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical nrocedures .
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The cystoscopes and accessories are used for visualizing body cavities and organs (via natural pessages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope s working channel.
The instruments are reusable; they are intended to be cleaned, sterilized and reused.
Device Description
The Trokamed GmbH Endoscopes and accessories consist of:
- A Various manually operated surgical instruments
- A Several Trocar sleeves and accessories, Verres insufflation cannula and suction-firrigation systems
- > Several Endoscopes (Arthroscope, Cystoscope)
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K Number
K060232Device Name
TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
Manufacturer
TROKAMED GMBH
Date Cleared
2006-07-12
(163 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
TROKAMED GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trokemed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.
The instruments are reusable; they are intended to be cleaned sterilized and reused.
Device Description
electrosurgical instruments and accessories
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