510(k) clearances

GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)

Gt Metabolic Solutions, Inc. · General, Plastic Surgery

K261467Substantially EquivalentTraditionalSAH
Open FDA's page for this record
Third party flag
N
City
St. Michael
Advisory committee description
General, Plastic Surgery
Address 1
5450 Quam Ave. NE
Address 2
Suite 100
Statement or summary
Summary
Product code
SAH
Zip code
55376
Applicant
Gt Metabolic Solutions, Inc.
Decision date
2026-09-16
Decision code
SESE
Country code
US
Device name
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)
Advisory committee
SU
Contact
Lisa Griffin Vincent
K number
K261467
State
MN
Date received
2026-05-04
Review advisory committee
SU
Postal code
55376
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
1450662, 3021969326, 3017462289, 3012448339
FEI number
1450662, 3021969326, 3017462289, 3012448339
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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.