Skip to content

Parker Quality & Compliance

PQC Reg Watch

Sponsor this week — one slot, $75, newsletter line and this bar

510(k) clearance

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

FDA 510(k) source

510(k) number
K261467
Applicant
Gt Metabolic Solutions, Inc.
Decision date
Sep 16, 2026
Date received
May 4, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
SAH
Device type
Magnetic Compression Anastomosis System
Device class
Class II
Regulation
21 CFR 878.4816
Advisory committee
General, Plastic Surgery
Statement or summary
Summary
Third party
N
Location
St. Michael, MN, US