510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243213Substantially Equivalent

Self-Forming Magnet (FLEX SFM)

GI Windows, Westwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243213 is the FDA 510(k) clearance record for Self-Forming Magnet (FLEX SFM), a class II device, cleared for GI Windows, Inc. on under FDA product code SAH (Magnetic Compression Anastomosis System). FDA's definition for product code SAH 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...". FDA records list 4 510(k) clearances for GI Windows, Inc., from to . As of , FDA records show no recalls naming K243213.

Clearance record

Decision date
Received
(118 days to decision)
Product code
SAH Magnetic Compression Anastomosis System
Regulation
21 CFR 878.4816
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
GI Windows, Inc. 380 University Ave., Westwood MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAH

Trailing 12 months
3 clearances under product code SAH in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260