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510(k) Data Aggregation
K Number
K153258Device Name
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
Manufacturer
Surgical Instrument Service and Savings (dba Medline ReNewal
Date Cleared
2016-04-05
(147 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings (dba Medline ReNewal
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Device Description
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and the trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.
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K Number
K143166Device Name
Medline ReNewal Reprocessed Compression Limb Sleeves
Manufacturer
Surgical Instrument Service and Savings (dba Medline ReNewal
Date Cleared
2015-01-16
(73 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings (dba Medline ReNewal
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
Device Description
Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.
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