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510(k) Data Aggregation
K Number
K151308Device Name
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Manufacturer
SCHOELLY FIBEROPTIC, GMBH
Date Cleared
2016-02-09
(267 days)
Product Code
FGA, FEC, FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SCHOELLY FIBEROPTIC, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.
The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
Device Description
The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".
Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.
In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.
The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.
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K Number
K132009Device Name
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
Manufacturer
SCHOELLY FIBEROPTIC, GMBH
Date Cleared
2014-04-09
(282 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
SCHOELLY FIBEROPTIC, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhinoflaryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
Device Description
The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.
The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.
The endoscope further incorporates a ventilation system to protect the shaft. The exhaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.
The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition and is already CE marked.
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K Number
K992362Device Name
FLEXISCOPE IQ 101
Manufacturer
SCHOELLY FIBEROPTIC, GMBH
Date Cleared
1999-08-05
(21 days)
Product Code
FET
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SCHOELLY FIBEROPTIC, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scholly Flexiscope IQ 101 is indicated for video visualization of sites in conjunction with endoscopic devices.
Device Description
Not Found
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K Number
K984641Device Name
FLEXISCOPE OPTOMODUL
Manufacturer
SCHOELLY FIBEROPTIC, GMBH
Date Cleared
1999-03-29
(88 days)
Product Code
EIA, DEC
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SCHOELLY FIBEROPTIC, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexiscope Optomodul is indicated for use during dental in the country bear when a video image is desired. The Flexiscope Optomodul Is Indreason 2007 - 100 mm a video image is desired.
Device Description
Not Found
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