510(k) clearances

FLOW FLEXTEND Wand (72290039)

ArthroCare Corporation · General, Plastic Surgery

K254122Substantially EquivalentTraditionalGEI
Open FDA's page for this record
Third party flag
N
City
Austin
Advisory committee description
General, Plastic Surgery
Address 1
7000 W. William Cannon Dr.
Statement or summary
Summary
Product code
GEI
Zip code
78735
Applicant
ArthroCare Corporation
Decision date
2026-03-30
Decision code
SESE
Country code
US
Device name
FLOW FLEXTEND Wand (72290039)
Advisory committee
SU
Contact
Alexander Brankner
K number
K254122
State
TX
Date received
2025-12-19
Review advisory committee
SU
Postal code
78735
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
3010816547, 1824199, 3007748817, 3016851379, 3020904959, 3021008900, 3010805941, 1418975, 3007593903, 3007648309, 3030446844, 2650143, 3005467144, 2183319, 3006546082, 3015241782, 1828132, 3008114965, 3010400367, 3008933393, 8010273, 3006990600, 1717344, 8030607, 3032391, 3012322232, 9613563, 1519132, 1218017, 2133936, 3016168848, 3011782009, 3006555617, 3013944123, 2022435, 9611516, 3021632375, 2649614, 3009212837, 1225492 +831 more
FEI number
3010816547, 1824199, 3007748817, 3016851379, 3020904959, 3021008900, 3010805941, 1418975, 3007593903, 3007648309, 3030446844, 3005467144, 2183319, 3006546082, 3015241782, 1828132, 3008114965, 3010400367, 3008933393, 3006990600, 1717344, 3005276402, 3012322232, 1519132, 1218017, 3000280067, 3016168848, 3006555617, 3013944123, 2022435, 3021632375, 2649614, 3009212837, 3013077751, 2242352, 3010069773, 3020968442, 1643817, 3012204368, 3002807072 +831 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.