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510(k) Data Aggregation
K Number
K083556Device Name
MODIFICATION TO AUTO-BAND LIGATOR
Manufacturer
SCANDIMED INTERNATIONAL
Date Cleared
2009-02-19
(79 days)
Product Code
MND, REG
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
SCANDIMED INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
Device Description
The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel.
The only modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations.
The Auto-Band Ligator incorporates the following product features:
- Automatic Reverse Movement to START position after each release
- Snap Fixation system ensures stable fixation on the scope
- Adjustable Snap Fixation System facilitates fixation on all brands of scopes
- Precision One-Step Release Mechanism of bands
- Only a single band can be released at a time
- Latex or Latex Free Rubber Bands
- Available in 5, 6, 7, 8 or 10 band configurations
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K Number
K081142Device Name
AUTO-BAND LIGATOR
Manufacturer
SCANDIMED INTERNATIONAL
Date Cleared
2008-05-16
(24 days)
Product Code
MND
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
SCANDIMED INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
Device Description
The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only change being proposed in this current Special 510(k) Premarket Notification is to convert the original latex rubber ligating bands to latex free rubber ligating bands. The Auto-Band Ligator incorporates the following product features: Automatic Reverse Movement to START position after each release. Snap Fixation system ensures stable fixation on the scope. Adjustable Snap Fixation System facilitates fixation on all brands of scopes. Precision One-Step Release Mechanism of bands. Only a single band can be released at a time. Latex Free Rubber Bands. Available in 5, 7 or 10 band configurations.
Ask a Question
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