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510(k) Data Aggregation
K Number
K003965Device Name
MRI SAFE INSTRUMENTS
Manufacturer
AESCULAP, INC.
Date Cleared
2001-03-16
(84 days)
Product Code
GEA
Regulation Number
878.4800Why did this record match?
Product Code :
GEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982472Device Name
GENICON TROCAR
Manufacturer
GENICON, LC
Date Cleared
1999-02-04
(204 days)
Product Code
GEA
Regulation Number
878.4800Why did this record match?
Product Code :
GEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.
Device Description
This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated.
Trocar Tip:
- A modified pyramidal tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula.
Trocar Handle:
- Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion.
Cannula:
- Clear casing for visualization of instrument and tissue passage. .
- Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use.
- . Extended CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer cap is easier to remove and replace than the Apple silicone cap.
- . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.
Valve:
- . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use.
- . A pull-tab was added to facilitate removal of the valve during specimen retrieval.
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