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Found 3 results
510(k) Data Aggregation
K Number
K010305Device Name
WEISS RETINAL CANNULA
Manufacturer
MICRON SURGICAL, INC.
Date Cleared
2001-05-02
(90 days)
Product Code
HMX
Regulation Number
886.4350Why did this record match?
Product Code :
HMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000457Device Name
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
Manufacturer
RETINALABS.COM
Date Cleared
2000-05-09
(88 days)
Product Code
HMX
Regulation Number
886.4350Why did this record match?
Product Code :
HMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970873Device Name
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
Manufacturer
AMERICAN MEDICAL DEVICES, INC.
Date Cleared
1997-05-20
(71 days)
Product Code
HMX
Regulation Number
886.4350Why did this record match?
Product Code :
HMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For irrigation/aspiration during eye surgery
Device Description
The American Medical Devices, Inc 19 and 20 ga. Endosoft™ Soft Tip Needles are for irrigation/aspiration during eye surgery. The device consists of a stainless steel needle with a plastic luer lock on one end and a protruding piece of soft silastic tubing at the tip. This device connects to any conventional extrusion handpiece with a male luer lock adapter.
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