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510(k) Data Aggregation
K Number
K051979Device Name
ORS MODEL 6000 ENDOSCOPE HOLDER
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2005-08-30
(40 days)
Product Code
OCT, KOG
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
O.R. SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS 6000 Endoscope Holder is a single use disposable device as an accessory for ORS Solution Warmers. The ORS 6000 Endoscope Holder is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.
Device Description
The ORS 6000 Endoscope Holder (figures 1) is designed to prevent fogging or wetting of the scope eyepiece by providing a hold for the scope, which keeps it above the water line of the warm solutions. The ORS 6000 Endoscope Holder is manufactured from GE VALOX thermoplastic polyester resins. The ORS Endoscope Holder is a single use disposable device. The ORS 6000 Endoscope Holder is used with ORS-2000 Solution Warmer K921633 and ORS-2000LD Solution Warmer K021289.
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K Number
K023282Device Name
ORS-3000LD
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-11-13
(43 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
O.R. SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.
Device Description
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile.
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K Number
K023283Device Name
1075LD HUSH-SLUSH
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-11-13
(43 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
O.R. SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.
Device Description
Not Found
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K Number
K021288Device Name
ORS-1000LD
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-06-27
(65 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
O.R. SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.
Device Description
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.
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K Number
K021289Device Name
WARMER 2000LD
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-06-26
(64 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
O.R. SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORS-2000LD is designed to warm and maintain the temperature of surgical solutions prior to their use.
Device Description
Not Found
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K Number
K960836Device Name
DMS-9000
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
1996-09-12
(196 days)
Product Code
LRJ
Regulation Number
880.6890Why did this record match?
Applicant Name (Manufacturer) :
O.R. SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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