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510(k) Data Aggregation
K Number
K111480Device Name
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
Manufacturer
TECHNOLOGY DELIVERY SYSTEMS, INC.
Date Cleared
2012-04-04
(313 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
TECHNOLOGY DELIVERY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times
Device Description
The Maxi-Flex Semi Flex Scopes™ is flexible endoscope that allows operator-controlled deflection of the distal end or tip of the scope. The devices will be made available in lengths (25 cm and 65 cm), each length with a working channel. With a Maxi-Flex accessory a 'Y Port' the working channel may be utilized as an irrigation channel.
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K Number
K062725Device Name
MAXIFLEX-SEMI FLEX SCOPE
Manufacturer
TECHNOLOGY DELIVERY SYSTEMS, INC.
Date Cleared
2006-09-29
(16 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
TECHNOLOGY DELIVERY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MaxiFlex Semi Flex Scopes™.are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures
Device Description
Not Found
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K Number
K013300Device Name
MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
Manufacturer
TECHNOLOGY DELIVERY SYSTEMS, INC.
Date Cleared
2002-04-16
(195 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TECHNOLOGY DELIVERY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver lase energy to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and cosmetic surgery. The MaxiFlex fiber is intended for energy delivery for ablating, incising, excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted above using a contact fiber optic based laser system.
The device is suitable for use for all applications for which the laser output unit is cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.
Device Description
The delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 400, and 1000um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The fiber is stripped of its protective jacket in accordance with the laser manufacturers instructions and is cleaved to provide laser radiation output.
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