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Found 5 results
510(k) Data Aggregation
K Number
K993361Device Name
TUBING EXTENSION SET
Manufacturer
HURRICANE MEDICAL
Date Cleared
2000-01-04
(90 days)
Product Code
MSR
Regulation Number
886.4150Why did this record match?
Product Code :
MSR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
Device Description
The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.
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K Number
K983448Device Name
ML UNIVERSAL TUBING
Manufacturer
MED-LOGICS, INC.
Date Cleared
1998-12-18
(79 days)
Product Code
MSR
Regulation Number
886.4150Why did this record match?
Product Code :
MSR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.
Device Description
Med-Logics, Inc., Administration Set (UT 3004)
Med-Logics, Inc., Drainage Bag (UT 3002)
Med-Logics, Inc., Universal Tubing Set (UT 3000)
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K Number
K980849Device Name
SURGIN KIT
Manufacturer
SURGIN SURGICAL INSTRUMENTATION, INC.
Date Cleared
1998-07-09
(154 days)
Product Code
MSR
Regulation Number
886.4150Why did this record match?
Product Code :
MSR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.
Device Description
Not Found
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K Number
K980100Device Name
STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
Manufacturer
STORZ INSTRUMENT CO.
Date Cleared
1998-06-01
(140 days)
Product Code
MSR
Regulation Number
886.4150Why did this record match?
Product Code :
MSR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.
Device Description
The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.
The Storz DP4210 Venturi Economy Anterior Pack is provided non-sterile and contains reusable components consisting of an anterior collection cassette, I/A tubing set, and I/A test chambers. The Storz DP5000 ASC Daypack is provided sterile and contains both reusable and single use components. The DP5000 reusable items include an anterior collection cassette, I/A test chambers, needle wrench, and infusion sleeve. The DP5000 single use items include an I/A tube assembly and a BSS administration tube assembly.
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K Number
K972522Device Name
ML-DISPOSABLE PAK
Manufacturer
MED-LOGICS, INC.
Date Cleared
1997-09-30
(85 days)
Product Code
MSR
Regulation Number
886.4150Why did this record match?
Product Code :
MSR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in cataract surgery to irrigate and aspirate cataract material.
Device Description
Not Found
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