510(k) clearances

Facet Aurora Reusable Lancet Base

Facet Technologies, LLC · General, Plastic Surgery

K232912Substantially EquivalentTraditionalQRL
Open FDA's page for this record
Third party flag
N
City
Atlanta
Advisory committee description
General, Plastic Surgery
Address 1
3900 N. Commerce Dr.
Statement or summary
Summary
Product code
QRL
Zip code
30344
Applicant
Facet Technologies, LLC
Decision date
2024-01-25
Decision code
SESE
Country code
US
Device name
Facet Aurora Reusable Lancet Base
Advisory committee
SU
Contact
James Bonds
K number
K232912
State
GA
Date received
2023-09-19
Review advisory committee
SU
Postal code
30344
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Multiple Use Blood Lancet For Single Patient Use Only
Medical specialty description
General, Plastic Surgery
Regulation number
878.4850
Device class
2
Registration number
3013298431, 3011121740, 8043792, 3008191276, 3015058854, 3010830834, 1058602, 3004130086, 3003674698, 3007134734, 3009578786, 3007363438, 3013223546, 3017500903, 3002680783, 1066444, 3006899020, 3011065399, 9611444, 3044026004, 3003741676, 3024512705, 3018940143, 3003041175, 3006532271, 3045951983, 3010160527, 3025413691, 3009498548, 3038419886, 3012118659, 3038356900, 9613304, 3030186688, 3004468256, 3005644014, 3009171251, 3008780388, 3011617315, 3004146366 +46 more
FEI number
3013298431, 3008191276, 3015058854, 3004130086, 3003674698, 3007134734, 3009578786, 3002808269, 3013223546, 3017500903, 1000600761, 3002680783, 3006899020, 3011065399, 3044026004, 3003741676, 3024512705, 3018940143, 3003041175, 3006532271, 3002807040, 3045951983, 3025413691, 3009498548, 3038419886, 3012118659, 3038356900, 1000219614, 3030186688, 3004468256, 3005644014, 3008780388, 3011617315, 3002807423, 1000525253, 3004146366, 3004183148, 1832816, 3003405786, 3008801456 +46 more
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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.