510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SAHClass II

Magnetic Compression Anastomosis System

21 CFR 878.4816 / General, Plastic Surgery
FDA source (opens on fda.gov)

SAH is the FDA product code for Magnetic Compression Anastomosis System, a class II device type, regulated under 21 CFR 878.4816. FDA's definition for this code reads: "A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery system. Compression and necrosis of tissue between magnet devices is...". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAH
Device name
Magnetic Compression Anastomosis System
FDA definition
A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery system. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally. This classification does not include devices intended for weight loss or metabolic disease treatment
Regulation
21 CFR 878.4816
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code SAH

By decision year
9 clearances under product code SAH with a decision year between 2024 and 2026, 2025 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code SAH by decision year
YearClearances
20242
20254
20263

Applicants with the most clearances

Product code SAH
Applicants holding the most 510(k) clearances under product code SAH
ApplicantClearances
GI Windows4
GT Metabolic Solutions, Inc.4
Gt Metabolic Solutions, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code