510(k) clearances

MagDI System (MAG-02, DS-01)

Gt Metabolic Solutions, Inc. · General, Plastic Surgery

K243359Substantially EquivalentTraditionalSAH
Open FDA's page for this record
Third party flag
N
City
San Jose
Advisory committee description
General, Plastic Surgery
Address 1
3050 Three Springs Ct.
Statement or summary
Summary
Product code
SAH
Zip code
95140
Applicant
Gt Metabolic Solutions, Inc.
Decision date
2025-02-28
Decision code
SESE
Country code
US
Device name
MagDI System (MAG-02, DS-01)
Advisory committee
SU
Contact
Lisa Griffin Vincent
K number
K243359
State
CA
Date received
2024-10-29
Review advisory committee
SU
Postal code
95140
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Magnetic Compression Anastomosis System
Medical specialty description
General, Plastic Surgery
Regulation number
878.4816
Device class
2
Registration number
3017462289, 3021969326, 3012448339, 1450662
FEI number
3017462289, 3021969326, 3012448339, 1450662
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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.