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

REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS

K Number: K024015 · Decision Mar 4, 2003
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
36
Review Days
90

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Basic Information

Device Name
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K Number
K024015
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Alliance Medical Corp.
Date Received
December 4, 2002
Decision Date
March 4, 2003
Product Code
NLM
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
NLM Laparoscope, General & Plastic Surgery, Reprocessed

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K052918 REPROCESSED EXTERNAL FIXATION DEVICES
K052603 REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
K052414 REPROCESSED ELECTROPHYSIOLOGY CATHETER
K052064 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
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