FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

ENDOSURG DISPOSABLE SECONDARY TROCAR

K Number: K940036 · Decision May 12, 1994
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
1
Review Days
128

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Basic Information

Device Name
ENDOSURG DISPOSABLE SECONDARY TROCAR
K Number
K940036
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1390
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Endosurg
Date Received
January 4, 1994
Decision Date
May 12, 1994
Product Code
DRC
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DRC Trocar

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