510(k) clearances

Kahook Dual Blade Glide (KDB Glide)

New World Medical, Inc. · General, Plastic Surgery

K220891Substantially EquivalentTraditionalQUQ
Open FDA's page for this record
Third party flag
N
City
Rancho Cucamonga
Advisory committee description
General, Plastic Surgery
Address 1
10763 Edison Ct.
Statement or summary
Summary
Product code
QUQ
Zip code
91730
Applicant
New World Medical, Inc.
Decision date
2024-05-17
Decision code
SESE
Country code
US
Device name
Kahook Dual Blade Glide (KDB Glide)
Advisory committee
SU
Contact
Victor Arellano
K number
K220891
State
CA
Date received
2022-03-28
Review advisory committee
OP
Postal code
91730
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Knife, Intraocular Pressure Lowering
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
1000125279, 2032521, 3013023969
FEI number
1000125279, 3003574398, 3013023969
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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.