510(k) clearances

VIA360™ Surgical System

New World Medical, Inc. · General Hospital

K243503Substantially EquivalentTraditionalMRH
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Third party flag
N
City
Rancho Cucamonga
Advisory committee description
General Hospital
Address 1
10763 Edison Ct.
Statement or summary
Summary
Product code
MRH
Zip code
91730
Applicant
New World Medical, Inc.
Decision date
2025-02-14
Decision code
SESE
Country code
US
Device name
VIA360™ Surgical System
Advisory committee
HO
Contact
Sartaj (Taj) Kaur-Hurrle
K number
K243503
State
CA
Date received
2024-11-12
Review advisory committee
OP
Postal code
91730
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Pump, Infusion, Ophthalmic
Medical specialty description
General Hospital
Regulation number
880.5725
Device class
2
Registration number
3010363671, 1920664, 1932402, 3019924, 1000125279, 3007113251, 3017616393, 3042158861, 2029275, 1313525, 2953359, 3009746061, 3005641545, 1450662, 2183477, 3004748528, 2246552
FEI number
3010363671, 1920664, 3019924, 1317628, 3007113251, 1000125279, 3017616393, 3042158861, 3000215205, 3009746061, 3005641545, 1450662, 1000119053, 2183477, 3004748528, 1000306431, 2246552
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.