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

INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES

K Number: K940731 · Decision Sep 13, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
6
Review Days
207

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Basic Information

Device Name
INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES
K Number
K940731
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Innervision, Inc.
Date Received
February 18, 1994
Decision Date
September 13, 1994
Product Code
GCJ
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
GCJ Laparoscope, General & Plastic Surgery

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K Number Device Name
K992345 CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
K991877 MACMED PAEDIATRIC INTRAMEDULLARY NAIL
K982428 CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
K940750 INNERVISION,INC. LAPAROSCOPIC ELECTRODES
K940718 INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS