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510(k) Data Aggregation
K Number
K050957Device Name
EUTROCHAR
Manufacturer
SPECIAL DEVICES, INC.
Date Cleared
2005-05-18
(33 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
SPECIAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR USE IN INSTALLING SURGICAL DRAINS
Device Description
The EuTrochar is a trocar used for the installation of surgical drains. The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement and to keep fingers away from the sharp point. Trocars have been used for more than a hundred years to create an incision in soft tissue for surgical drain tubing. Like other drain installation trocars, this instrument is a highly polished stainless steel rod of small diameter, normally 4 to 6mm in diameter and about 160mm long. One end of the rod is very sharply pointed and the other end has a hose barb for affixing tying. The rod is curved between the two ends so that it looks like a giant sailmaker's needle.
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K Number
K982354Device Name
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
Manufacturer
SPECIAL DEVICES, INC.
Date Cleared
1998-11-23
(140 days)
Product Code
HTN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SPECIAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use of the SD Trans-Osseous Fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.
Device Description
Not Found
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