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