510(k) clearances

INUMI™ Flex Needle

Galvanize Therapeutics, Inc. · General, Plastic Surgery

K233884Substantially EquivalentTraditionalOAB
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Third party flag
N
City
Redwood City
Advisory committee description
General, Plastic Surgery
Address 1
3200 Bridge Pkwy.
Statement or summary
Summary
Product code
OAB
Zip code
94065
Applicant
Galvanize Therapeutics, Inc.
Decision date
2024-05-22
Decision code
SESE
Country code
US
Device name
INUMI™ Flex Needle
Advisory committee
SU
Contact
Deborah Sheffield
K number
K233884
State
CA
Date received
2023-12-08
Review advisory committee
SU
Postal code
94065
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Low Energy Direct Current Thermal Ablation System
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
2244478, 3015540957, 3008849319, 3016020790, 1319211, 3021023752, 3017448139, 1721676, 1319639, 3043527620, 3017185164, 9611854, 2031093, 3017892510, 3040004547, 1000523114
FEI number
3002807258, 3001236549, 3015540957, 3008849319, 1000138054, 3016020790, 1000136269, 3021023752, 3017448139, 1721676, 1319211, 3043527620, 3017185164, 3017892510, 3040004547, 1000523114
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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.